Integra SURGICAL TECHNIQUE. MemoFix Super Elastic Nitinol Staple System. Super Elastic Nitinol Staple System

Transcription

1 Integra MemoFix Super Elastic Nitinol Staple System SURGICAL TECHNIQUE Super Elastic Nitinol Staple System

2 Table of Contents Design Rationale...2 System Features...2 Indications...2 Contraindications...2 Surgical Technique...3 Step 1 Size Selection...3 Step 2 Drilling/Placement...3 Step 3 Staple Insertion...4 Step 4 Staple Position...5 Step 5 Tamping... 6 Step 6 Verification/Closure... 6 Removal... 6 Instrumentation Ordering Information...Back Cover

3 Design Rationale The MemoFix staples are manufactured from biocompatible, super elastic nitinol and require no specialized storage or temperature sensitive handling. Using proprietary manufacturing processes, Integra has created staples that produce markedly better compressive forces at final in-vivo position, while also presenting a much smaller dorsal profile. The color coded instrumentation allows surgeons to more accurately place the staples while using a simplified system. The staples are offered in a wide range of sizes and configurations to cover most common extremity procedures. MemoFix vs. Leading Competitors MemoFix System Features No specialized handling or temperature sensitive storage required Delivers maximum compression within the in-vivo position range Micro-edge barb technology provides maximum pull-out resistance Domed design of staple bridge reduces the dorsal profile Easy to use color coded instrumentation Indications The MemoFix Staple System is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet. The MemoFix Staples are intended for single use only. Contraindications Use of the staple system is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients with inadequate bone stock; in patients with certain metabolic diseases; in patients with high levels of activity; in patients who are not able to comply with post-operative treatment protocols. The staple contains nickel and should not be used in patients where sensitivity to nickel or other metal is suspected. If material sensitivity is suspected, appropriate tests should be performed prior to implantation. 2

4 Surgical Technique As the manufacturer of this device, Integra does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and using the appropriate techniques for implanting the device in each patient. Step 1 Size Selection Prepare the bone for the corresponding fixation or fusion required to achieve the desired correction. Using the sizer/drill guide, select the desired staple bridge length by adjusting the handles until the right handle tip is locked into place directly above the marked number indicating the bridge length. Place the barbed ends of the sizer/drill guide against the bone and verify that the selected bridge length is appropriate for the patient anatomy. Step 2 Drilling/Placement Note The staple spreaders, drills and pins are color coded to correspond with the various staple sizes. Select the appropriate color instruments for the corresponding staple size that is being utilized. Once the staple size has been determined, select the corresponding drill for the staple and drill one side of the fixation or fusion site. Remove the drill and place a temporary anchoring pin through the drill guide and into the bone. Drill the second hole on the other side of the fixation or fusion site. Note Optional drill stops can be used on one or both sides if precise drilling depth is desired (2-2). Remove the drill and temporary pin

5 Step 3 Staple Insertion Load the staple into the staple spreader (3-2) and secure the staple by squeezing the handles until the staple legs are engaged Continue to slowly squeeze the handles until the staple legs are parallel (3-3)

6 Step 3 Staple Insertion (Continued) To maintain the desired distraction of the staple, turn the knob on the locking bar until it touches the handle (3-4). This will accurately maintain the staple shape during placement without the need to continue squeezing the handles of the spreader. Place the distracted staple into the predrilled holes and press the staple in until the staple spreader is almost flush with the bone. Step 4 Staple Position Disengage the staple spreader from the staple by lifting the locking bar from the slot on the handle while gently squeezing the handles so they do not snap closed. Carefully remove the tips of the jaws from underneath the staple bridge. 5

7 Step 5 Tamping Using the tamp, push the staple into the bone until the underside of the bridge is flush with the top surface of the bone. Additional tamping on each of the staple bridge corners can further reduce the profile of the final staple position. Note Use of a mallet is optional. Step 6 Verification/Closure Verify the placement of the staple is correct. Verification can be confirmed by utilizing a mini C-arm (or equivalent) in multiple axes. If additional compression or stabilization is desired, multiple staples can be used by repeating Steps 1-5. The incision can be closed with the suture material of choice. Post operative care is according to surgeon preference and should follow protocol for fixation or fusions of a similar nature. Removal: If it becomes necessary to remove a staple, the removal tool can be utilized to lift the staple bridge to a position allowing the staple spreader to be engaged. Once the staple spreader is engaged, the handles can be squeezed to distract the legs sufficiently to remove the staple. 6

8 Integra MemoFix Super Elastic Nitinol Staple System Implants Instrumentation Reference MS MS MS MS MS MS MS MS MS MS MS MS MS MS MS MS MS MS Description MemoFix Staple 08mm x 08mm x 08mm MemoFix Staple 10mm x 10mm x 10mm MemoFix Staple 10mm x 15mm x 13mm MemoFix Staple 10mm x 17mm x 15mm MemoFix Staple 12mm x 10mm x 10mm MemoFix Staple 12mm x 15mm x 13mm MemoFix Staple 12mm x 17mm x 15mm MemoFix Staple 12mm x 19mm x 16mm MemoFix Staple 15mm x 12mm x 12mm MemoFix Staple 15mm x 15mm x 15mm MemoFix Staple 18mm x 12mm x 12mm MemoFix Staple 18mm x 14mm x 14mm MemoFix Staple 18mm x 17mm x 15mm MemoFix Staple 18mm x 19mm x 17mm MemoFix Staple 20mm x 15mm x 15mm MemoFix Staple 20mm x 20mm x 20mm MemoFix Staple 25mm x 20mm x 20mm MemoFix Staple 25mm x 22mm x 22mm Reference MS2610 MS2620 MS2630 MS2640 MS2650 MS2660 MS2708 MS2710 MS2712 MS2714 MS2716 MS2719 MS2722 MS2810 MS2815 MS2820 MS2900 MS2920 MS2930 Description MemoFix Drill Bit - 1.7mm MemoFix Drill Bit mm MemoFix Drill Bit - 2.7mm MemoFix Pin - 1.7mm MemoFix Pin - 2.0mm MemoFix Pin - 2.7mm MemoFix Drill Stop Adapter - 8mm MemoFix Drill Stop Adapter - 10mm MemoFix Drill Stop Adapter - 12/13mm MemoFix Drill Stop Adapter - 14/15mm MemoFix Drill Stop Adapter - 16/17mm MemoFix Drill Stop Adapter - 19/20mm MemoFix Drill Stop Adapter - 22mm MemoFix Staple Spreader - 8, 10, 12mm MemoFix Staple Spreader - 15, 18mm MemoFix Staple Spreader - 20, 25mm MemoFix Drill Guide MemoFix Tamp MemoFix Pickup Forceps MS2940 MemoFix Removal Tool MT3000 MemoFix Sterilization Instrument Tray MT4000 MemoFix Staple Sterilization Tray Caddy Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. n Warning: Applicable laws restrict these products to sale by or on the order of a physician. n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use. For more information or to place an order, please contact: United States, Canada, Asia, Pacific, Latin America USA fax n International fax n integralife.com/contact Manufacturer: Ascension Orthopedics, Inc Metric Blvd Austin, TX USA n MemoFix, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M LC Rev. B EN