Integra LifeSciences Corporation
DigiFuse Cannulated Intramedullary Fusion System Instructions for Use
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In soft bone cases, broaching can be eliminated at the surgeons discretion. 3 . Using the included guide wire, drive the wire into the center of the resection site parallel to the longitudinal axis of the phalanx. Advance the wire through the medullary canal into the subchondral bone, closest to the MP joint. Intra-operative radiographs should be taken at this time to verify proper positioning of the guide wire. If the guide wire is not positioned in the center of the proximal phalanx, repeat Step 3, until proper positioning is achieved. 4. After the guide wire is correctly placed, select the appropriate sized implant based on the size of the proximal phalanx and previously selected plantar correction. Place the distal end of the threaded portion of the implant over the guide wire, and push the implant up to the resection site. 5. Slide the driver (0° or 10°) over the guide wire, and engage the barbed end of the implant. Care should be taken to make sure the 0° or 10° driver is utilized on the corresponding 0° or 10° implant. Turn the screw into the proximal phalanx until the threaded portion of the implant is completely or near completely recessed into the phalanx, and the dorsal mark on the driver is aligned in the 12 o’clock position. It is important to leave blade tips proud of the proximal phalanx to maximize engagement in the middle phalanx. 6. Manually distract the middle phalanx, and place the broached hole over the barbed end of the implant that is protruding from the proximal
phalanx using care to align the broached hole with the implant blade. Using firm pressure, press the middle phalanx onto the barbed end until the resected surfaces of the middle and proximal phalanx meet. Once the implant is fully seated, check manually for retention. Verification can be confirmed by utilizing intra-operative radiographs in multiple axes. Close the incisions with the suture material of choice. Post-operative care is according to surgeon preference and should follow protocol for fusions of a similar nature.
Caution: • Federal (United States) law restricts this device for sale by or on the order of a medical practitioner licensed to do so. • Do not attempt a surgical procedure with faulty, damaged or suspect Integra instruments or implants. Inspect all components preoperatively to assure utility.
Sterility - DigiFuse The DigiFuse implants and instruments are packaged non-sterile and must be sterilized prior to surgical use. Sterility Type: Pre-Vacuum Steam Sterilization Exposure Temp: 270°F (132°C) Exposure Time: 4 minutes Dry Time: 20 Minutes Condition: Wrapped Sterility Type: Gravity Steam Sterilization Exposure Temp: 270°F (132°C) Exposure Time: 15 Minutes Dry Time: 20 Minutes Condition: Wrapped PRODUCT INFORMATION DISCLOSURE INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA EXCLUDES ALL WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS. DigiFuse, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2017 Integra LifeSciences Corporation. All rights reserved. LC-04-5040-0002 Rev. B 12/17 0836707-1
Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, TX 78758 i USA Tel: 1 (512) 836-5001 Fax: 1 (512) 836-6933 integralife.com
DigiFuse® Cannulated Intramedullary Fusion System Instructions for Use Description The Integra® DigiFuse® Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. Available implants and instrumentation are packaged as a single system and are also available separately as individual components. The system includes instruments (guide pins, broach, insertion / removal drivers) to facilitate the placement of the implants.
Material
Possible Adverse Effects
The implants are constructed from implant grade titanium alloy (Ti 6Al-4V ELI) per ASTM F-136. The instrumentation is made from titanium and stainless steel.
The following are specific adverse effects which should be understood by the surgeon and explained to the patient. These do not include all adverse effects which can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
Clinical Indications The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include: •H ammer toe deformity •C law toe deformity • Mallet toe deformity • Other deformities of the feet and hands The DigiFuse implants and guide wires are intended for single use only.
Contraindications Use of the DigiFuse implant is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; in patients with inadequate bone stock; in patients with certain metabolic diseases; in patients with high levels of activity; or in patients who are not able to comply with post-operative treatment protocols.
4. U se of an incorrectly sized implant in areas of high functional stresses may lead to implant failure. 5. The DigiFuse hemi implant has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating or migration in the MR environment.
1. Infection.
Maintaining Device Effectiveness
2. Pain, discomfort or abnormal sensations due to the presence of the implant.
1. T he surgeon should have specific training, experience, and thorough familiarity with the use of DigiFuse implant devices or similar intramedullary fusion devices.
3. Metal sensitivity or allergic reaction to a foreign body. 4. Migration of the implant; loosening of the implant. 5. Delayed wound healing or deep wound infection resulting in possible removal of the implant. 6. Fracture of the implant due to non-compliance to post operative regimen or improper implant selection.
Warnings 1. Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure. If corrective action is not taken, complications may occur. 2. Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site. 3. Instruments, guide wires and screws are to be treated as sharps.
2. The surgeon must exercise reasonable judgment when deciding which DigiFuse Implant type to use for specific indications. 3. The implants are not intended to endure excessive abnormal functional stresses. 4. A ll DigiFuse implants and instruments may be required for each surgery. Failure to use dedicated, unique Integra instruments and implants for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury. Failed devices may require reoperation and removal. 5. C arefully inspect the implants prior to use. Inspect the instruments before and after each procedure to assure they are in proper operating condition. Instruments which are faulty, damaged or suspect should not be used. They should be replaced or sent to Integra for disposition and repair.
6. I ntegra recommends the use of Integra products in a sterile environment. 7. F or best results and to ensure proper working condition, after cleaning the Ratchet Handle (DF1500), a non-silicone lubricant should be used per the manufacturer’s instructions.
Instructions for Use 1. P erform an incision, of the surgeon’s choice, over the proximal interphalangeal (PIP) joint. Reflect the soft tissues surrounding the PIP joint to completely expose it for resection. Determine at this point if the 0° or 10° plantar correction implant will be utilized. While standard perpendicular osteotomies will provide effective results, any resection cuts at this point can be made to reflect the eventual use of the corresponding chosen implant as it relates to plantar correction. Complete the resection of the PIP joint in preparation for PIP joint fusion. 2. Position the tip of the broach on the middle phalanx in the correct orientation, and insert the broach while holding the middle phalanx to secure it. The broach features a marked line indicating the correct dorsal positioning of the implant when situated in the phalanx and should be oriented in the 12 o’clock position during broaching. The broach should be inserted until the shoulder contacts the resected portion of the middle phalanx.