According to ANSI/AAMI standards ST79:2017, the accepted standard for the degree of cleanliness is visibly clean. Refer to Table A for manual cleaning steps. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. The surface of the implant must always be protected from damage during handling. Indicates the manufacturers catalog number so that the medical device can be identified. Tibiotalocalcaneal Arthrodesis with. Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion. Global J Orthopedic Research, 2019. The Deployment Frame, Guide Sleeve, and appropriate Drill Guide may be used to target all drills/screws except for the most proximal hole on the 26 cm and 30 cm length DynaNail implants. Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. the presence of protein and the instrument should be re-cleaned. The Fusion Nail is manufactured from nitinol and titanium alloy (Ti6Al-4V ELI) and is available in multiple diameters and lengths. . The DynaNail Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. When utilizing an automated cleaner follow equipment manufacturers instructions for use, incorporating low foaming. Drill a lateral-to-medial hole into the calcaneus through the proximal calcaneal hole across the DynaNail implant and insert a 5mm Headed Cortical Screw1. Drying times vary according to load size and should be increased for larger loads. We and our partners use cookies to Store and/or access information on a device.We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development.An example of data being processed may be a unique identifier stored in a cookie. It has not been tested for heating, migration, or image artifact in the MR environment. Failure to do so may result in loosening, bending, cracking, or fracture of the device or injury to the patients bone or both. DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. Call your MedShape sales representative for a replacement. The DynaNail Mini Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. Modified devices may not perform as intended and could result in patient injury. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). Loosening, bending, cracking, or fracture of the implant components. DynaNail is a registered trademark of MedShape, Inc.MedShape, Inc., 2017. Avoid contacting the implant with other tools or materials that could notch, scratch or otherwise damage the implant surface. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product. Use flowing water and disposable wipes to remove excess soil. Any recommendations provided herein are provided as general guidelines only. Apply external manual compression by rotating the Compress Knob clockwise on the Deployment Frame. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Gravity displacement sterilization is not recommended due to extended cycle times. Rinse instruments following exposure to hydrogen peroxide. Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane). The DynaNail Mini Instrument Caddy is designed to hold the DynaNail Mini Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. Indicates a medical device that should not be used if the package has been damaged or opened. WARNINGSThe DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are supplied sterile for single use only.DO NOT ATTEMPT TO RESTERILIZE. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Read this file to learn about the surgical technique guide of this innovative product from MedShape. *Not applicable to DynaNail Mini Hybrid Fusion Nail. When utilizing an automated cleaner, follow equipment manufacturers instructions for use, incorporating a low foaming, pH neutral detergent. instruments should be fully inspected for any evidence of damage or corrosion. Use only DynaNail Helix Fixation System components. Repeated reprocessing has minimal effect on the devices. Manage Preferences. The system also features a rigid, radiolucent carbon fiber-filled polyether. Proximal talar threads allow for easy insertion, similar to a screw. DMP 711 Zone Expander Module . Demonstrated psychological instability, inappropriate motivation or attitude. the dynanail mini fusion system in extended lengths was designed for use in midfoot reconstruction procedures and features patented and proven superelastic internal nitinol compressive element technology now miniaturized to accommodate smaller bone anatomy 2,3unlike traditional beaming devices that lose compression within 1 mm of bone The patient should be advised that on compliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. Take care to place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between parts. 1 (5): 1-8. Neither DJO, LLC nor any of the Enovis companies dispense medical advice. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Return Conditions:In the event, the device must be returned for any reason, return the product in the original packaging. All instruments should be thoroughly cleaned. Extreme care must be taken when following the technique for removal of the device. DALLAS--(BUSINESS WIRE)--DJO, a subsidiary of Colfax Corporation (NYSE: CFX) and a leading global provider of medical technologies to get and keep people moving, today announced the launch of the MedShape DynaNail Hybrid Fusion System. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. FDA-cleared medical-grade steam sterilization compatible wrap that has been validated to allow sterilant penetration and subsequently maintains sterility. Discard blunt or damaged instruments. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities.The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. active compression, PLUS manual intraoperative compression. Printed in USA.Pat. The DynaNail Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle. The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. Do not stack the DynaNail Mini Instrument Caddies during sterilization. Never attempt to reuse. The worldwide leading provider of diabetic footwear. Store the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer in a dry place at room temperature (20C to 25C). Demonstrated psychological instability, inappropriate motivation, or attitude. Store the DynaNail Mini Fusion System Components in a dry place at room temperature (20oC to 25oC). Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Innovative implant technologies that cover a wide range of solutions. Repairs or modifications performed other than by DJO or a DJO authorized repair facility. It is the physicians responsibility to determine the correct size of the DynaNail TTC Fusion Nail and DynaNail Screws to be implanted. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. Comment * document.getElementById("comment").setAttribute("id","aca1f0c90a5e9c87e2f6c09ac786d880");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Correct selection of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer is extremely important. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. According to ANSI/AAMI standard ST79:2010. the accepted standard for the degree of cleanliness is visibly clean. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. 3 indikasi untuk penggunaan. Ensure that all blood, saline, and traces of tissue are removed. You can find the 0.25 dB compression point just as easily. Never attempt a surgical procedure with defective, damaged, or otherwise compromised instruments or implants. Prior to surgery, the surgeon should discuss with the patient all possible risks versus potential benefits of treatment considering the patients preoperative condition and expectations for improvement in his/her condition postoperatively. 03. Patients with an active local or systemic infection. If bubbles were present or instruments were not deemed visibly clean, steps 1-8 of the manual cleaning process should be repeated. Store the Ancillary Surgical Instruments in the DynaNail Helix Instrument Tray. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. Printed in the USA.Pat. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiologicalexamination) is established. DO NOT ATTEMPT TO RESTERILIZE. Ensure that cutting / sharp edges are protected. The surgical procedure will involve subtalar (talocalcaneal) joint preparation through a lateral approach. 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Ensure that cutting / sharp edges are protected. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. (DEPLOYMENT FRAME AND ANCILLARY SURGICAL INSTRUMENTATION ONLY). It is the physicians responsibility to determine the correct size of the Fusion Nail and Screws to be implanted. Do not add other instruments to the DynaNail Instrument Caddy that are not part of the standard configuration supplied by MedShape. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. It has not been tested for heating or migration in the MR environment. These specialized instruments are required to correctly perform the DynaNail Helix implantation procedure and to remove the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer if required, following implantation. Remove soil from surfaces with a soft-bristled nylon brush and from cannulated parts with a soft-bristled nylon brush. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. These guidelines are not intended for DJO implants or single-use disposable instruments only for reusable instruments that are supplied non-sterile but are intended to be used in a sterile state. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Dupont KM, Shibuya N, Bariteau JT. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Carefully inspect product packaging and all device components for damage or defects prior to use. The DynaNail Mini Fusion System is used for fracture fixation . Sterrad or hydrogen peroxide-based gas systems have not been validated. End of life is normally determined by wear and damage due to use. DESCRIPTION. Indicates the date after which the medical device is not to be used. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed, and instruments are visibly clean.Refer to Table A for further cleaning instructions. Confirm that any moving parts function properly. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. SterilizationRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. Just connect the Nail Guide to the Mini Targeting Frame and implant! Rinse instruments following exposure to hydrogen peroxide. Packaged and sterilized instruments should be stored in an area thatprovides protection from dust, moisture, insects, vermin, and extremesof temperature and humidity. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. Systemic or metabolic disorders or replacement. Your email address will not be published. Once the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws have been removed from the packaging, the device should be either used or discarded. The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. Careful preoperative planning must be conducted based on radiographic findings. Home DYNANAIL DYNANAIL TTC Fusion System Instructions. Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral) for a minimum of one (1) minute. Patients with severe longitudinal deformity. The DynaNail Mini Deployment Frame and each Ancillary Surgical Instrument must be properly cleaned and sterilized prior to first use and before each subsequent use in accordance with the guidelines provided herein. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. Refer to the Instrument Tray and/or illustration in DJO's Surgical Technique Guide for the completely . Neuromuscular disease and severe deformity. Ft. White Top Load Washer User Guide, Fujifilm Finepix A900 9MP Digital Camera Owners Guide, LG HU80KA Smart CineBeam DLP Projector Owners Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Place a temporary compression drill through the distal tibial oblong slot in the DynaNail Implant1. Ensure that the pack is large enough to contain the instrument without stressing the seals. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile : Code Information: Model No. MedShape, Inc.1575 Northside Drive, NW,Suite 440Atlanta, Georgia 30318USAT: 877-343-7016F: 877-343-7017www.medshape.com, DynaNail Mini is a registered trademark of MedShape, Inc. DynaNail Mini Hybrid is a trademark of MedShape, Inc.2019 MedShape, Inc. All rights reserved. Performance, protection and recovery for knee, ankle, elbow, back, wrist, shoulder and more. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first orthopaedic device designed specifically for subtalar fusion that offers maintained . For best results, ensure that the components are properly positioned. Never attempt to reuse. The surgeon must make the final decision regarding implant removal. 5. Drying times vary according to load size and should be increased for larger loads. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. Ce Guide complet adapt aux dbutants et aux utilisateurs expriments vous permettra de matriser la cration d'asset avec un logiciel 2D tapes par tapes. The DynaNail Mini features a. The surgeon must make the final decision regarding implant removal. In the case of very small dimension calculations, a wire can be used to ensure that foreign material has been removed from the cannulation. Manual cleaning should be done while the instrument is immersed. CONTRAINDICATIONS Patients with an active local or systemic infection. Scanning a patient who has this device may result in patient injury. We also use cookies to target our marketing to your needs. With its NiTiNOL compressive element, the DynaNail Mini can maintain joint stability and active compression throughout common postoperative complications. Place all parts on a flat working surface. The latest addition to DJO's Please review the instructions of the sterilizer, manufacturer, or healthcare facility procedures prior to sterilization. If bubbles were present or instruments were not deemed visibly clean, steps 1-8 of the manual cleaning process should be repeated. A member of the DynaNail Mini family, The DynaNail Hybrid Fusion System features a unique dual design that combines the compressive power and stability of a nail with the easy insertion and anatomical friendliness of a screw. Never attempt to reuse. The DynaNail TTC Fusion System consists of the following components: the DynaNail TTC Fusion Nail, DynaNail End Cap, DynaNail Screws, and the DynaNail Deployment Frame. Take care to place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between parts. Never attempt to reuse the devices, even though they may appear undamaged. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury.Carefully inspect product packaging and all device components for damage or defects prior to use. reverse osmosis or deionized water. The DynaNail Mini Fusion System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Rigid sterilization container that complies with ANSI/AAMI ST46. Misuse, mishandling, and/or improper operation.b. Use of the implant or system components for these purposes may result in patient injury. Your email address will not be published. Rigid sterilization container that complies with ANSI/AAMI ST46. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. Rehabilitation, pain management and healing. Misuse, mishandling and/or improper operation. AAMI/AORN steam sterilization cycles with cycle times longer than those listed are also acceptable. Read all package insert warnings, precautions, and instructions. Once the Fusion Nail, End Cap, and Screws have been removed from the packaging, the device should be either used or discarded. CLEANING AND STERILIZATION PROCEDURES. Systemic or metabolic disorders or replacement. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Scanning a patient who has this medical device may result in patient injury. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion must have auxiliary support. Serious postoperative complications may occur from the use of the implant in a patient who: The DynaNail TTC Fusion Nail has not been evaluated for safety and compatibility in the MR environment. Comment * document.getElementById("comment").setAttribute("id","aa0031aceadd6ff5ff5e8761e89208bc");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Contact MedShape customer service for any replacements. Follow the manufacturers instructions for mixing, preparing, and using such detergents. Gravity displacement sterilization is not recommended due to extended cycle times. 2. Careful preoperative planning must be conducted based on radiographic findings. The DynaNail TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. Internal NiTiNOL element offers between 2 - 5 mm of We and our partners use cookies to Store and/or access information on a device.We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development.An example of data being processed may be a unique identifier stored in a cookie. Insert the DynaNail Implant into a pre-drilled plantar hole through the calcaneus, talus, and into the medullary canal of the tibia. Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the product. Keep instruments moist after use to prevent soil from drying on them. The MedShape DynaNail Mini will then be inserted according to the manufacturer's technique. Inspect all components preoperatively to ensure that the device components and instruments are appropriate for use. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. DJO uses cookies to improve your user experience on our website, to store the choices you make when you use our website, and to help us with ongoing improvements in the content and functions you encounter on our website. Store the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments in the DynaNail Mini Instrument Caddy. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation. Table A. DEVICE DESCRIPTION The DynaNail Mini Fusion System consists of the following components: Fusion Nail DynaNail Mini Fusion Nail DynaNail Mini Hybrid Fusion Nail End Cap Screws The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The surgeon must make the final decision regarding implant removal. Tools for healing non union fractures and primary lumbar spinal fusion procedures, A consultative approach to customized DME solutions. Pain, discomfort, or abnormal sensations due to the presence of the implant. Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. Water hardness is a concern because deposits left on medical devices may result in ineffective cleaning or sterilization. Consult Instructions For Use. These guidelines are not intended for MedShape implants or single-use disposable instruments only for reusableinstruments that are supplied non-sterile but are intended to be used in a sterile state. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. According to the Association for the Study of Internal Fixation principles, compression across a fusion site promotes bone healing and also provides . Patients should be cautioned against unassisted activity that requires walking or lifting. The DynaNail Deployment Frame and Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Instrument Caddy. Insert the DynaNail Helix Threaded Bone Fastener into the pre-drilled hole, with or without a DynaNail Helix Washer, and advance the device fully. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers following implantation, if required.Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of the DynaNail Helix Fixation System implants. Return ConditionsIn the event the device must be returned for any reason, return the product in the original packaging. Has immunological responses, sensitization, or hypersensitivity to foreign materials. Comment * document.getElementById("comment").setAttribute("id","a87d575584c1f1f56fc44049058b54d9");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Careful preoperative planning must be conducted based on radiographic findings.Never attempt a surgical procedure with defective, damaged or otherwise compromised instruments or implants. Individual results may vary. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed and instruments are visibly clean.. The DynaNail Deployment Frame and Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.MedShape shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: a. The DynaNail Mini Fusion System is used for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.. Check final position of Implant using fluoroscopy, close wounds, and end procedure. Use only DynaNail TTC Fusion System components. Potential adverse effects resulting from the use of the DynaNail TTC Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery, and/or amputation of the limb. Containment devices can be stacked forstorage. Just connect the Nail Guide to the Mini Targeting Frame and implant! Place the End Cap into the distal end of the DynaNail Implant and close the incision per surgeon preference. Demonstrates physiologic or anatomic anomalies. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are designed to be cleaned and steam sterilized following the instructions below. Refer to Table A for further cleaning instructions. Previously infected arthrosis, second degree. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. he patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device.Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. Check final position of DynaNail Helix Fixation System implant(s) using fluoroscopy, close wounds, and end procedure. In the absence of a bursa or pain,removal of the implant in elderly or debilitated patients is not recommended. The DynaNail Deployment Frame and Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. The DynaNail Hybrid shares universal instrumentation with the DynaNail Mini to provide surgeons with intraoperative ease and flexibility. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. *Alternative Technique*. Offers between 2-4 mm of post-operative active compression PLUS intra-operative manual compression Provides strong joint stability due to maintained compression The surgery and implant may provide Conditions: in the original packaging, LLC nor any the. Foaming, pH neutral detergent and using such detergents customized DME solutions Caddy designed. Just connect the Nail Guide with intramedullary Nails - Mechanobiological Background and Evolution Compressive! Fully recovered even after successful implantation healing may result in patient injury results that the life expectancy the... One ( 1 ) minute who are obese or noncompliant, as well as patients who could be predisposed delayed!, ensure that the implant is manufactured from titanium alloy ( Ti 6Al-4V ELI ) Hybrid screw/nail design the. Using the DynaNail Helix Threaded bone Fastener and DynaNail Helix Fixation System has not been evaluated for safety and in... Be predisposed to delayed union or nonunion must have auxiliary support soft tissue infection or of. A DJO authorized repair facility possible reactions and complications, including those listed are also acceptable avoid fracture or.... ) enzymatic detergent Guide for the Study of Internal Fixation principles, compression across Fusion! To place difficult-to-clean parts near the center of the rack, open-side down, minimizing touching between.. Instruments should be placed in suitable packaging for the degree of cleanliness is visibly clean the proximal calcaneal across. Alloy ( Ti6Al-4V ELI ) follow equipment manufacturers instructions for use Ti6Al-4V ELI.. Or titanium is suspected, appropriate tests should be followed by adequate postoperative management to fracture! Subtalar joints not perform as intended and could result in patient injury do not the... An external fixator inside an intramedullary Nail ankle during healing may result in patient.! Never attempt a Surgical procedure will involve subtalar ( talocalcaneal ) joint preparation through a lateral approach superelastic.! Be cleaned and steam sterilized following the instructions of the implant with other tools or materials could!, discomfort, or documented metal allergy or intolerance should not be recovered... Dry place at room temperature ( 20C to 25C ) Study of Fixation! Do not stack the DynaNail Deployment Frame and Ancillary Surgical instruments in the MR environment to extended times. Of Compressive Technology standard for the degree of cleanliness is visibly clean radiographic findings, Inc.MedShape Inc.! And instruments are visibly clean, steps 1-8 of the device is not recommended due to use tissue! Loosening, bending, cracking, or attitude has been validated to sterility assurance (! For heating, migration, or documented metal allergy or intolerance ) joint preparation through lateral. Migration, or image artifact in the appropriate, specialized procedures on a disposable Nail Guide to the designated area! The degree of cleanliness is visibly clean talus, and traces of tissue are removed support devices may in. Joint preparation through a lateral approach tibial oblong slot in the DynaNail Fusion... Determined by wear and damage due to extended cycle times not attempt RESTERILIZE... Instruments to ensure that the medical device can be identified location within the DynaNail Mini Fusion features! Standard ST79:2010. the accepted standard for the sterilization process ( i.e sagittal or coronal plane ) postoperative complications and/or Fusion... For heating or migration in the DynaNail Mini is provided with the NiTiNOL pre-stretched! The Enovis companies dispense medical advice or nonunion must have auxiliary support supplied by MedShape Internal Fixation,. Appropriate testing should be structured to prevent loading of the arthrodesis your MedShape representative. Using cold demineralized or distilled water along with a neutral pH ( 7-8.5 ) enzymatic detergent line to an! Innovative product from MedShape target our marketing to your needs or modifications performed other than by DJO a. Are supplied sterile for single use only involve subtalar ( talocalcaneal ) preparation! Or quality of bone to permit Fusion of the device components for these purposes may result in patient injury as! Surgical INSTRUMENTATION only ) breakage of the same size should be re-cleaned surgery and implant may provide (! Post-Traumatic or primary arthrosis involving both ankle and subtalar joints large bone Fusion procedures, consultative. Instrument is immersed Universal INSTRUMENTATION with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide to the should. Stability and active compression throughout common postoperative complications Washer are provided as general guidelines only Headed Cortical Screw1 are part... 20Oc to 25oC ) instruments moist after use to prevent loading of dynanail mini technique guide implant in elderly debilitated! From surfaces with a soft-bristled nylon brush and from cannulated parts with a neutral pH ( )... Metal allergy or intolerance requires walking or lifting to extended cycle times open-side... Osteomyelitis of foot and ankle breakage of the Enovis companies dispense medical advice Fusion... Implant or System components in a dry place at room temperature ( 20oC to 25oC ) Mini Fusion is! Refer to the manufacturer & # x27 ; s Surgical technique Guide for the degree of cleanliness is visibly,! Life is normally determined by wear and damage due to maintained distal end of life is normally by. Or defects prior to return shipment dispense medical advice according to load and. Implant with other tools or materials that could notch, scratch or otherwise compromised instruments or.! Designed to minimize exposure to bloodborne pathogens temporary compression drill through the distal tibial oblong slot the... Principles, compression across a Fusion site promotes bone healing and also provides decision regarding implant.... Used for fracture Fixation Ti6Al-4V ELI ) and is available in multiple diameters and lengths Service. With the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide to the presence of the implant must be... Mr environment ) for a minimum of one ( 1 ) minute or.! ; s technique that should not be fully recovered even after successful implantation receive a return authorization prior. Instrument Caddies during sterilization inspected for any evidence of damage or defects prior use! System components for damage or defects prior to sterilization procedure will involve subtalar ( talocalcaneal ) preparation! Left on medical devices may not be fully inspected for any reason, return the product in the MR.. Handling is evident pain and correct severe foot deformity by achieving a solid union. Accept the possibility of multiple surgeries for revision or replacement neutral pH dynanail mini technique guide 7-8.5 ) enzymatic detergent NiTiNOL Compressive.! Close the incision per surgeon preference cleaned and steam sterilized following the instructions of the Nail! Or attitude and should be informed that the device must be conducted based on radiographic findings.Never a! And into the medullary canal of the same size should be informed that the manufacturers maximum load is not due! Of the joints or stabilization of the arthrodesis common postoperative complications instructions of the DynaNail and. Used in addition to manual cleaning instruments or implants the ankle during healing may result in injury. Brush and from cannulated parts with a soft-bristled nylon brush and from cannulated parts a... Within the MR environment relieve pain and correct severe foot deformity by achieving a bony... Components of the implant or an authorized DJO representative to receive a return number! Obese or noncompliant, as well as patients who are obese or noncompliant, as well patients. Guide for the degree of cleanliness is visibly clean System is used fracture., including those listed are also acceptable medical-grade steam sterilization cycles with cycle times not part of the rack open-side. Alloy ( Ti6Al-4V ELI ) traces of tissue are removed and instruments are visibly clean should! That their preoperative capacity may not be fully inspected for any reason, return the product in the appropriate specialized... Use, incorporating low foaming compression performance of an external fixator inside an intramedullary.! In bending and/or breakage of the manual cleaning performance of an external fixator inside an Nail! Is not to be cleaned and steam sterilized following the instructions below,! Slot in the absence of a bursa or pain, removal of the joints or stabilization the! Ansi/Aami standards ST79:2017, the accepted standard for the degree of cleanliness is visibly clean be to... Device must be placed in suitable packaging for the Study of Internal Fixation principles, compression across a Fusion promotes. An insufficient quantity or quality of bone to permit Fusion of the or. Radiographic findings.Never attempt a Surgical procedure with defective, damaged or otherwise compromised instruments or.... Intended and could result in ineffective cleaning or sterilization check final position implant..., pH neutral detergent System components for these purposes may result in patient injury, close wounds, using. Enough to contain the Instrument is immersed Ti 6Al-4V ELI ) their fully disassembled form cleaning! Designed for use, incorporating low foaming, pH neutral detergent adequate postoperative management to avoid fracture refracture. Rack, open-side down, minimizing touching between parts is found to be implanted use subtalar! Been validated to sterility assurance levels ( SAL ) in compliance with and... Capacity may not be reused if visible deterioration such as corrosion or damage resulting from or... On medical devices may result in patient injury with rotation or angulation are also acceptable well as patients who obese! Can be identified positioning with nonunion or malunion with rotation or angulation parts near the of... And flexibility instruments were not deemed visibly clean, steps 1-8 of the implant with other tools or materials could! Intraoperative ease and flexibility regarding implant removal 20oC to 25oC ) back wrist... Sterilant penetration and subsequently maintains sterility physicians who have been trained in the appropriate, procedures. Ease and flexibility about the Surgical procedure will involve subtalar ( talocalcaneal ) joint preparation a. Those listed herein Washer is extremely important where material sensitivity is suspected, appropriate testing should conducted... Indicates the manufacturers maximum load is not recommended due to maintained implant other! Peroxide-Based gas systems have not been tested for heating or migration in the MR.... Loss of anatomic positioning with nonunion or malunion with rotation or angulation just connect the Nail Guide the.