Staple Fixation System Implants Instruments Applications
Contents Introduction 3 Instrument Use - Universal Inserter 4 Instrument Use - Universal Rod 5 Ordering Information - Implants 6 Ordering Information - Instruments 7 2
Introduction When the stapling of bones, ligaments, tendons or soft tissue is part of an operative procedure, then the new advanced Staple Instrumentation System combined with a complete family of Fixation Staples offers clear-cut advantages. Implants Instruments The Stryker Staple System consists of eight different Staple designs. They differ in their function and indication. The Ellison Arched Bridge Staples are designed to reduce the risk of the staple backing out of the bone and to reattaching tubular soft tissue to bone. The Ellison Flat Staples are used to attach bone to bone. The Ellison removable Soft Tissue Retainer can be used with the flat Staple for soft tissue reattachment. All Ellison Staples are barbed on all four sides of the legs for enhanced fixation and protection against back out. Depalma Staple same indication as the Ellison Arched Bridge Staple but without barbed legs. The Blount Epiphyseal Staples are applicable for epiphyseal applications in children and adolescents. The reinforced corners reduce unwanted staple bending and allow accurate staple driving. Stepped Staples provide the most comprehensive approach to bone fixation following high tibial osteotomies. These staples are available in three offset steps (5, 10 and 15mm) The Kremser Staple for HTO can be locked with a standard 4.5mm self tapping cortical screw through a special locking hole in the distal leg. Fracture Staples have slightly tapered legs. This feature creates compression when the staples are driven in bone. Wire Staples are indicated for fragment fixation, particularly in small fragments and where inter-fragmental screw fixation is not possible. All staples are manufactured from Vitallium alloy, fully conforming to the requirements set by ASTM F799/ISO 5832 standards. The upgraded instrumentation system features a unique universal staple inserter for accurate staple impaction into bone. The special holding/tightening mechanism enables secure gripping of the staples and allows easy exchange of the three different clamping jaws. The system also includes a universal rod to connect the final impactor, extraction spoon and a extraction hook together with a slotted hammer. A swivel drill guide for pre-drilling cortical bone is available as an optional item. All instruments are stored in a plastic sterilization case together with a tray for staples. The tray with preformed inserts holds a variety of Staples for easy intra-operative selection. 3
Instrument Use Universal Inserter Assembling the Inserter Three different clamping jaws are available for insertion of the staple range. If the jaws need changing the following procedure must be followed: Turn the knob anti-clockwise until it disengages from the threaded shaft. Remove the spring and push the shaft forward through the instrument casing. Select the appropriate clamping jaws and place the two parts on the distal end of the shaft using the transverse pegs. Firmly press the jaws on the shaft and re-insert the shaft through the casing. Ensure that the two pegs engage in the longitudinal slots in the casing. Keep the clamping jaws pressed against the conical end of the casing. Slide the spring over the threaded end of the shaft and reattach the knob to the thread. Turn the knob clockwise and advance until a gap of approx. 5mm to the proximal end of the casing has been reached. Using the inserter Spread the clamping jaws by pushing the knob against the casing and insert the selected staple correctly in the chosen clamping jaws. Release the pressure on the knob so that the spring-loaded mechanism keeps the staple fixed in the jaws. Tighten the knob until firm resistance can be felt, confirming secure fixation of the staple in the clamping jaws. After impaction of the staple into the bone, turn the knob anti-clockwise several turns and release the instrument by pushing the knob against the casing. 4
Instrument Use Universal Rod The Universal Rod has been designed for the use with the Final Impactor, the Extraction Spoon and the Extraction Hook. Select the correct instrument and attach it to the rod using the threaded end. Check secure fixation with the 8mm open wrench on the flat parts of the instruments. Final impaction of staples can be carried out using the rod with the attached Impactor and the Hammer. The Extraction Spoon is used to lift the staple off the bone until final extraction can be carried out using the Extraction Hook and the slot of the Hammer over the Universal Rod. 5
Ordering Information - Implants ELLISON Arched Bridge Fixation Staples WIRE Staples 6982-1-009 N/A 9 23 6982-1-012 N/A 12 23 6982-1-015 N/A 15 23 6586-1-005 N/A 10 16 6586-2-005 N/A 16 16 6586-3-005 N/A 22 16 ELLISON Flat Bridge Fixation Staples 6982-2-008 N/A 8 23 6982-2-011 N/A 11 23 6982-2-014 N/A 14 23 FRACTURE Staples Straight 6986-0-005 N/A 16 22 6986-0-007 N/A 22 22 ELLISON Optional Soft Tissue Retainers 6982-3-008 N/A 8 N/A 6982-3-011 N/A 11 N/A 6982-3-014 N/A 14 N/A DEPALMA Soft Tissue Staples 6985-3-003 N/A 10 19 6985-3-006 N/A 19 19 BLOUNT Staples Epiphyseal (with reinforced corners) 6985-0-003 N/A 10 22 6985-0-005 N/A 16 22 6985-0-007 N/A 22 22 6985-0-011 N/A 27 22 KREMSER* High Tibial Osteotomy Staple 6987-7-035 14 35 38 Note: *ISO 4.5mm Cortical Screw recommended STEPPED High Tibial Osteotomy Staples 6987-1-005 5 28 33 6987-3-010 10 28 38 6987-5-015 15 28 43 6
Ordering Information - Instruments REF Description 6983-1000 Universal Inserter 6983-1010 Clamping Jaws, blue (for Blount, Stepped, Fracture and Kremser Staples) 6983-1020 Clamping Jaws, yellow (for Ellison Staples) 6983-1030 Clamping Jaws, green (for Depalma and Wire Staples) 1806-0113 Universal Rod 6983-3000 Final Impactor 6983-4000 Extraction Spoon 6983-4050 Extraction Hook 1806-0130 Open Wrench 8/10 6983-5000 Slotted Hammer, small 6983-9000 Storage Case with Tray Insert, Implants 6983-9100 Tray Insert, Implants Optional 6983-2000 Swivel Drill Guide for 2.5mm Drill Spare Parts E6983101 E6983102 E6983103 Knob for Universal Inserter Spring for Universal Inserter Shaft for Universal Inserter 7
Trauma, Extremities & Deformities Trauma, Extremities & Deformities Biologics Biologics Surgical Products Surgical Products Neuro & ENT Neuro & ENT Stryker Trauma GmbH Prof.-Küntscher-Strasse 1-5 D-24232 Schönkirchen Germany www.osteosynthesis.stryker.com The information presented in this brochure is intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which products and techniques to use with their patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its subsidiary owns the registered trademark: Stryker Literature Number: B1000053 LOT B1007 Copyright 2007 Stryker Printed in Germany