Integra LifeSciences Corporation

DigiFuse Cannulated Intramedullary Fusion System Instructions for Use

2 Pages

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.
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File Name: Integra LifeSciences Corporation - LC-04-5040-0002 - DigiFuse Cannulated Intramedullary Fusion System Instructions for Use - 2017-12 - Rev B.pdf

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