THE MEMORY STAPLE SURGICAL TECHNIQUE

THE MEMORY STAPLE SURGICAL TECHNIQUE

TABLE OF CONTENTS Introduction PAGE 1 Features and Benefits PAGE 1 Ordering Information PAGE 2-3 Indications PAGE 4 Contra-indications PAGE 4 Surgical Technique PAGE 5-8 Common Procedures PAGE 9

Introduction The Memory Staple is an ideal form of fixation for arthrodesis, osteotomy and select fracture fixation. Manufactured from Nitinol, the BioPro Memory Staple offers continuous compression to help speed the bone healing. Nitinol is a shape memory alloy allowing the staple to offer active compression at the activation temperature of 98.60F (370C), patient body temperature. This eliminates the need for an external activation device while also offering benefits over pre-compressed staples such as more uniform compression. The S-Bend across the bridge of the BioPro Memory Staple ensures even compression across the fusion site, while maintaining a low profile against the bone. Features and Benefits The Memory Staple s unique activation method is complemented by simple, effective instrumentation that provides the surgeon with several intra-operative options for quick, reproducible results. Available in 17 standard sizes, plus six Step Staple options for calcaneal slides, the Memory Staple offers internal fixation with residual compression. The wide variety of sizes and styles make it ideal for most applications in the foot, ankle, hand and wrist. Compressed by patient body temperature S-bend in bridge induces compression across bridge 17 standard sizes 6 Step-staple sizes with offsets of 6mm, 9mm and 12mm Simple Instrumentation S-Bend Compressed at body temperature PAGE 1

Ordering Information The Memory Staple packaging is color coded for identification purposes. The headers on the table below represents the color code on the staple packaging as well as on the corresponding instrumentation. X-SMALL SMALL MEDIUM LARGE BRIDGE WIDTH LEG 1 LEG 2 WIRE SIZE ITEM # 7MM 5MM 5MM 1.2MM 17637 9MM 7MM 7MM 1.2MM 17638 7MM 5MM 5MM 1.5MM 17628 9MM 7MM 7MM 1.5MM 17629 11MM 8MM 8MM 1.5MM 17630 11MM 10MM 10MM 1.5MM 17631 13MM 10MM 10MM 1.5MM 17632 15MM 12MM 12MM 1.5MM 17633 11MM 15MM 13MM 1.5MM 17634 11MM 17MM 15MM 1.5MM 17635 11MM 19MM 17MM 1.5MM 17636 15MM 12MM 12MM 2.0MM 17625 18MM 18MM 15MM 2.0MM 17626 20MM 20MM 20MM 2.0MM 17627 20MM 20MM 20MM 2.0X3.0MM 17622 25MM 22MM 22MM 2.0X3.0MM 17623 30MM 30MM 30MM 2.0X3.0MM 17624 BRIDGE WIDTH LEG 1 LEG 2 WIRE SIZE STEP CALCANEAL STEP STAPLE 15MM 20MM 20MM 2.0X2.0MM 6MM 17715 15MM 20MM 20MM 2.0X2.0MM 9MM 17716 15MM 20MM 20MM 2.0X2.0MM 12MM 17717 20MM 20MM 20MM 2.0X3.0MM 6MM 17718 20MM 20MM 20MM 2.0X3.0MM 9MM 17719 20MM 20MM 20MM 2.0X3.0MM 12MM 17720 DRILL BITS DIAMETERS X-SMALL 1.4MM 17659 SMALL 1.8MM 17660 MEDIUM 2.4MM 17661 LARGE 3.0MM 17662 Bridge width x Leg 1 x Leg 2 - Wire diameter Bridge width Leg 1 Leg 2 Wire diameter PAGE 2

Memory Staple Instrument Kit STAPLE KIT (17707) Item # Description 17681 ADJUSTABLE DRILL GUIDE 17647 ANCHOR PIN 17656 SINGLE HOLE DRILL GUIDE 17648 ANGLED DRILL GUIDE 7-9MM 17649 ANGLED DRILL GUIDE 11-13MM 17650 ANGLED DRILL GUIDE 15-18MM 17651 SMALL STAPLE HEMOSTAT 17652 LARGE STAPLE HEMOSTAT 17653 LARGE STAPLE PUNCH 17654 SMALL STAPLE PUNCH 17655 ANGLED STAPLE PUNCH 17659 XSMALL STAPLE DRILL BIT - 1.4MM 17660 SMALL STAPLE DRILL BIT - 1.8MM 17661 MEDIUM STAPLE DRILL BIT - 2.4MM 17662 LARGE STAPLE DRILL BIT - 3.0MM 17708 INSTRUMENT TRAY PAGE 3

Indications Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. Fixation of soft tissue to bone such as anterior cruciate reconstruction. Contra-indications Comminuted bone surface which would militate against staple placement. Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple. Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. Important Note Any adjunctive procedures should be completed prior to staple implantation to avoid disrupting staple positioning. Immobilization, in addition to this internal fixation, until bone healing should be achieved by routine methods (casting, splints, etc.). Reduction of the site should be achieved and maintained prior to implanting the staple. The compressive force of the staple should not be relied upon to achieve closure or reduction of the fracture line. Care and Caution Inspect sterile pouches prior to use. Sterilization cannot be assured and staple should not be used if pouch or seal is damaged. Staples should be stored at 75ºF (24ºC) or less. Staples should be cooled to 75ºF (24ºC) prior to removing from the shipping block. Placing staples at -5ºF (-20ºC) will return staples to original position. The BioPro Memory Staples are a single use device. Do not autoclave staples. PAGE 4

Surgical Technique Fig. 1 The following technique demonstrates the use of the Memory Staple instrumentation. This technique can be applied to any procedure for successful implantation of the staple. Important Note: Always appose and temporarily fixate all bone fragments prior to drilling holes for staple implantation. Using the Adjustable Drill Guide Set the adjustable drill guide by pulling down on the set pin while sliding the guide bar until the desired staple size shows in the engraving window (Fig 1). Fig. 2 When using the adjustable drill guide, first drill the distal perpendicular hole, insert the anchor pin to stabilize the guide, then drill the proximal perpendicular hole (Fig 2). Fig. 3 Using the Single Hole and Angled Drill Guides To use the non-adjustable, angled drill guides start by drilling a perpendicular hole with the single hole drill guide (Fig 3). Fig. 4 Insert the pin on the end of the appropriately sized angled drill guide into the distal hole and coaptate the bone segments. Drill the proximal perpendicular hole using the angled drill guide (Fig 4). PAGE 5

Fig. 5 Staple Handling and Implantation Always use hemostats or the provided staple clamps to handle the BioPro Memory Staple. Warmth from a hand may prematurely activate the staple (Fig 5 & 6). Fig. 6 Fig. 7 Use the appropriate staple punch to ensure staples are fully inserted and seated against the bone (Fig 7). Fig. 8 After insertion, staples should sit flush against the bone. Staple compression will occur at body temperature, but may be hastened by irrigation with saline 98 F (37 C) to 100 F (38 C) (Fig 8). PAGE 6

Calcaneal Step Staple Technique The following is a step-by-step technique for use of the BioPro Calcaneal Step Staple. Fig. 9 Step One Calcaneal osteotomy is performed per surgeon s desired technique (Fig 9). Fig. 10 Step Two Choose the Step Staple Drill Guide for the appropriate width staple (either 15mm or 20mm). Place the center alignment pin within the osteotomy and ensure the handle is to the posterior side (Fig 10). Drill to a minimum depth of 20mm through both drill guide holes (all staple legs are 20mm long). Repeat for second staple location. PAGE 7

Fig. 11 Step Three Determine desired medial displacement and choose the appropriately sized staple. Step staples are available in 6mm, 9mm and 12mm offsets. Remove the staple from the shipping block with the provided hemostats. Note: Always handle staples with hemostats. Heat from a hand may prematurely activate the staple. Step Four Insert the staple into the drill holes and impact flush to the surface of the calcaneous with the included impactors. Ensure that both surfaces of the calcaneous are flush with the stepped bridge design of the staple (Fig 11). Repeat the above procedure for the second staple (Fig 12). Fig. 12 Step Five Staple activation may be hastened by applying warm saline to the staple. PAGE 8

Common Procedures The BioPro Memory Staple can be used in a wide variety of fixation cases. Here are a few examples of possible procedures and correct staple placement. Recommended staple sizes are noted. Foot and Ankle: 1. Hallux IP Fusion: 9x7,11x8,11x10,13x10 2. Hallux MPJ Fusion: 13x10,15x12,18x18x15 3. Lesser PIPJ Fusion: 7x5 1.2mm, 9x7 1.2mm 4. Austin, Youngswick, Reverdin Bunionectomies: 11x10,13x10x11x15x13 5. Base Wedge Osteotomies: 11x10,13x10,15x12,18x18x15 6. Akin Osteotomies: 7x5 1.2mm,9x7 1.2mm 7. Cotton Procedure: 20x20,18x18x15 8. Lapidus ProcedureL 20x20,18x18x15 Dorsally / 15x12 Medially 9. Talonavicular Fusion: 18x18x15,20x20 10. Calcaneal Cuboid Fusion: 15x12,18x18x15,20x20 11. Dwyer Osteotomy: 20x20 12 13 Hand and Wrist: 12.DIP Fusion: 7x5,9x7 13.PIP Fusion: 7x5,9x7 14.MCP Fusion: 11x8,11x10,13x10 15.Capitate/Scaphoid Fusion: 11x8,11x10,13x10 16. Capitate/Lunate Fusion: 11x8,11x10,13x10 17. CMC Thumb Fusion: 11x8,11x10,13x10 18. Third Metacarpal/Capitate Fusion: 11x8,11x10,13x10 19. Fifth Metacarpal/Hamate Fusion: 11x8,11x10,13x10 19 18 14 9 10 16 15 17 7 8 2 1 3 6 4 5 11 PAGE 9

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