Itegra MemoFix Super Elastic Nitiol Staple System SURGICAL TECHNIQUE Super Elastic Nitiol Staple System
Table of Cotets Desig Ratioale...2 System Features...2 Idicatios...2 Cotraidicatios...2 Surgical Techique...3 Step 1 Size Selectio...3 Step 2 Drillig/Placemet...3 Step 3 Staple Isertio...4 Step 4 Staple Positio...5 Step 5 Tampig... 6 Step 6 Verificatio/Closure... 6 Removal... 6 Istrumetatio Orderig Iformatio...Back Cover Desig Ratioale The MemoFix staples are maufactured from biocompatible, super elastic itiol ad require o specialized storage or temperature sesitive hadlig. Usig proprietary maufacturig processes, Itegra has created staples that produce markedly better compressive forces at fial i-vivo positio, while also presetig a much smaller dorsal profile. The color coded istrumetatio allows surgeos to more accurately place the staples while usig a simplified system. The staples are offered i a wide rage of sizes ad cofiguratios to cover most commo extremity procedures. MemoFix vs. Leadig Competitors MemoFix System Features No specialized hadlig or temperature sesitive storage required Delivers maximum compressio withi the i-vivo positio rage Micro-edge barb techology provides maximum pull-out resistace Domed desig of staple bridge reduces the dorsal profile Easy to use color coded istrumetatio Idicatios The MemoFix Staple System is idicated for fixatio ad arthrodesis of the associated boes ad joits of the hads ad feet. The MemoFix Staples are iteded for sigle use oly. Cotraidicatios Use of the staple system is cotraidicated i cases of active or suspected ifectio or i patiets who are immuocompromised; i patiets with iadequate boe stock; i patiets with certai metabolic diseases; i patiets with high levels of activity; i patiets who are ot able to comply with post-operative treatmet protocols. The staple cotais ickel ad should ot be used i patiets where sesitivity to ickel or other metal is suspected. If material sesitivity is suspected, appropriate tests should be performed prior to implatatio. 2
Surgical Techique As the maufacturer of this device, Itegra does ot practice medicie ad does ot recommed this or ay other surgical techique for use o a specific patiet. The surgeo who performs ay implat procedure is resposible for determiig ad usig the appropriate techiques for implatig the device i each patiet. Step 3 Staple Isertio 3-1 Step 1 Size Selectio 1-1 1-1 Prepare the boe for the correspodig fixatio or fusio required to achieve the desired correctio. Usig the sizer/drill guide, select the desired staple bridge legth by adjustig the hadles util the right hadle tip is locked ito place directly above the marked umber idicatig the bridge legth. Place the barbed eds of the sizer/drill guide agaist the boe ad verify that the selected bridge legth is appropriate for the patiet aatomy. 3-2 Load the staple ito the staple spreader (3-2) ad secure the staple by squeezig the hadles util the staple legs are egaged. 3-2 Step 2 Drillig/Placemet 2-1 2-1 The staple spreaders, drills ad pis are color coded to correspod with the various staple sizes. Select the appropriate color istrumets for the correspodig staple size that is beig utilized. Oce the staple size has bee determied, select the correspodig drill for the staple ad drill oe side of the fixatio or fusio site. Remove the drill ad place a temporary achorig pi through the drill guide ad ito the boe. Drill the secod hole o the other side of the fixatio or fusio site. 3-3 Cotiue to slowly squeeze the hadles util the staple legs are parallel (3-3). 3-3 Optioal drill stops ca be used o oe or both sides if precise drillig depth is desired (2-2). Remove the drill ad temporary pi. 2-2 3 4
Step 3 Staple Isertio (Cotiued) 3-4 Step 5 Tampig 5-1 3-4 To maitai the desired distractio of the staple, tur the kob o the lockig bar util it touches the hadle (3-4). This will accurately maitai the staple shape durig placemet without the eed to cotiue squeezig the hadles of the spreader. Place the distracted staple ito the predrilled holes ad press the staple i util the staple spreader is almost flush with the boe. 5-1 Usig the tamp, push the staple ito the boe util the uderside of the bridge is flush with the top surface of the boe. Additioal tampig o each of the staple bridge corers ca further reduce the profile of the fial staple positio. Use of a mallet is optioal. Step 4 Staple Positio 4-1 Step 6 Verificatio/Closure 6-1 4-1 Disegage the staple spreader from the staple by liftig the lockig bar from the slot o the hadle while getly squeezig the hadles so they do ot sap closed. Carefully remove the tips of the jaws from udereath the staple bridge. 6-1 Verify the placemet of the staple is correct. Verificatio ca be cofirmed by utilizig a mii C-arm (or equivalet) i multiple axes. If additioal compressio or stabilizatio is desired, multiple staples ca be used by repeatig Steps 1-5. The icisio ca be closed with the suture material of choice. Post operative care is accordig to surgeo preferece ad should follow protocol for fixatio or fusios of a similar ature. Removal: If it becomes ecessary to remove a staple, the removal tool ca be utilized to lift the staple bridge to a positio allowig the staple spreader to be egaged. Oce the staple spreader is egaged, the hadles ca be squeezed to distract the legs sufficietly to remove the staple. 5 6
Itegra MemoFix Super Elastic Nitiol Staple System Implats Istrumetatio Referece Descriptio Referece Descriptio MS080808 MemoFix Staple 08mm x 08mm x 08mm MS2610 MemoFix Drill Bit - 1.7mm MS101010 MemoFix Staple 10mm x 10mm x 10mm MS2620 MemoFix Drill Bit - 2.0 mm MS101513 MemoFix Staple 10mm x 15mm x 13mm MS2630 MemoFix Drill Bit - 2.7mm MS101715 MemoFix Staple 10mm x 17mm x 15mm MS2640 MemoFix Pi - 1.7mm MS121010 MemoFix Staple 12mm x 10mm x 10mm MS2650 MemoFix Pi - 2.0mm MS121513 MemoFix Staple 12mm x 15mm x 13mm MS2660 MemoFix Pi - 2.7mm MS121715 MemoFix Staple 12mm x 17mm x 15mm MS2708 MemoFix Drill Stop Adapter - 8mm MS121916 MemoFix Staple 12mm x 19mm x 16mm MS2710 MemoFix Drill Stop Adapter - 10mm MS151212 MemoFix Staple 15mm x 12mm x 12mm MS2712 MemoFix Drill Stop Adapter - 12/13mm MS151515 MemoFix Staple 15mm x 15mm x 15mm MS2714 MemoFix Drill Stop Adapter - 14/15mm MS181212 MemoFix Staple 18mm x 12mm x 12mm MS2716 MemoFix Drill Stop Adapter - 16/17mm MS181414 MemoFix Staple 18mm x 14mm x 14mm MS2719 MemoFix Drill Stop Adapter - 19/20mm MS181715 MemoFix Staple 18mm x 17mm x 15mm MS2722 MemoFix Drill Stop Adapter - 22mm MS181917 MemoFix Staple 18mm x 19mm x 17mm MS2810 MemoFix Staple Spreader - 8, 10, 12mm MS201515 MemoFix Staple 20mm x 15mm x 15mm MS2815 MemoFix Staple Spreader - 15, 18mm MS202020 MemoFix Staple 20mm x 20mm x 20mm MS2820 MemoFix Staple Spreader - 20, 25mm MS252020 MemoFix Staple 25mm x 20mm x 20mm MS2900 MemoFix Drill Guide MS252222 MemoFix Staple 25mm x 22mm x 22mm MS2920 MemoFix Tamp MS2930 MemoFix Pickup Forceps MS2940 MemoFix Removal Tool MT3000 MemoFix Sterilizatio Istrumet Tray MT4000 MemoFix Staple Sterilizatio Tray Caddy Availability of these products might vary from a give coutry or regio to aother, as a result of specific local regulatory approval or clearace requiremets for sale i such coutry or regio. Always refer to the appropriate istructios for use for complete cliical istructios. No cotractual documet. The maufacturer reserves the right, without prior otice, to modify the products i order to improve their quality. Warig: Applicable laws restrict these products to sale by or o the order of a physicia. For more iformatio or to place a order, please cotact: Uited States, Caada, Asia, Pacific, Lati America USA 800-654-2873 888-980-7742 fax Iteratioal +1 609-936-5400 +1 609-750-4259 fax itegralife.com/cotact Maufacturer: Ascesio Orthopedics, Ic. 8700 Camero Road, Suite 100 Austi, TX 78754 USA MemoFix, Itegra ad the Itegra logo are registered trademarks of Itegra LifeScieces Corporatio or its subsidiaries i the Uited States ad/or other coutries. 2015 Itegra LifeScieces Corporatio. All rights reserved. Prited i USA. 0M 0297802-1-EN LC-04-5050-0003