Integra. Large Uni-Clip Dual-Compression Staples SURGICAL TECHNIQUE
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1 Integra Large Uni-Clip Dual-Compression Staples SURGICAL TECHNIQUE
2 Table of Contents Design Rationale...02 Indications...02 Description...02 Surgical Technique...03 Surgical Site Preparation...03 Step 1: Drill Guide Positioning...03 Step 2: Drilling...03 Step 3: Assembly of the Impaction Device Step 4: Setting the Staple Step 5: Forceps Positioning...05 Step 6: Compression and Convergence...05 Tray Layout...07 Staple Options Ordering Information... Back Cover
3 Design Rationale The Large Uni-Clip compression staple is a quick and effective mechanical osteosynthesis system that provides compression between two osseous fragments. While its implementation is simple, the principles and limits of such a compression system must be respected. The Large Uni-Clip is manufactured from surgical stainless steel. Compression is achieved with a manually controlled deformation of the diamond in the bridge of the staple. This staple has various indications, including: forefoot, midfoot and hindfoot osseous procedures. Indications The Large Uni-Clip staples are indicated for fixation of bone fractures or for bone reconstruction: Arthrodesis in foot surgery Management of foot fractures Mono or bi-cortical osteotomies in the foot Distal or proximal metatarsal osteotomies Fixation of osteotomies for Hallux Valgus treatment Staple size should be chosen with respect to the specific indication. 2 interaxis sizes Description Controlled dual-compression staple Diamond designed bridge Internal notches for greater fixation Straight staple: Interaxis 20, leg lengths 20-20mm Interaxis 25, leg lengths 25-25mm Offset staple: Interaxis 25, leg lengths 20-25mm Interaxis 30, leg lengths 27-32mm Material: Stainless Steel Offset and straight staples Internal notches for an improved grip 316L ISO ASTM F138 & F139 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. Surgical Site Preparation The articular surfaces should be prepared using standard technique to resect the necessary amount of cartilage and, if necessary, to remove bone graft material. Obtain adequate reduction and provisional fixation using guide wires or reduction forceps. Procedure Bicortical osteotomy of the calcaneous with internal displacement. Step 1 Drill Guide Positioning Choose the appropriate implant (straight or offset). Adjust the drill guide ( ND straight or ND offset) according to the chosen staple s interaxis. The drill guide is positioned with the osteotomy centered between the two sleeves. Step 2 Drilling Prior to drilling, approximate the osteotomy. Prepare the proximal hole with the drill ( ND), and leave the drill in place. This will ensure proper positioning of the staple. The distal hole should then be prepared with the second drill. Leave both drills in place. Caution Large Uni-Clip staples are intended for mono-cortical use: no measurements are needed. 3
5 Step 3 Assembly of the Impaction Device Assemble the impaction device. Slide the impactor handle A ( ND) onto either side of the impactor attachment B ( ND). A B The side of the impactor attachment to be used, is determined by staple C. Place the choosen staple on the end of the impaction device. 3-2 A + B C Offset Staple Attachment Straight Staple Attachment Step 4 Setting the Staple A 4-2 Once the impaction device is fully assembled, remove the drills from the drill guide, maintaining contact between the guide and the drill holes. Angle the guide, keeping it in contact with the holes. Introduce the Large Uni-Clip staple by sliding the legs down the open side of the sleeves on the drill guide. Remove the drill guide. Impact the staple with the impaction device, so that the staple is flush with the surface A 4
6 Step 5 Forceps Positioning 5-1 Offset staple position Set the spreading forceps to the position corresponding to the appropriate implant.(straight or offset). Ensure the clamp is in the starting position, and insert the end of the spreading forceps ( ND) into the diamond of the staple. Straight staple position Starting position Step 6 Compression and Convergence Apply slight compression by bringing the two arms of the spreading forceps together, as shown in Figure 6-1. The legs of the staple will come together in a parallel fashion, as shown in Figure 6-2. Caution The action provided by the spreading forceps should not be used to approximate the positioning of the osseous fragments. 6-3 The fragments should have been previously positioned, along with any reduction that may be necessary. In this way, the spreading forceps provide compression between fragments. After the initial compression, the lever of the instrument can be used to apply the additional compression, as shown in Figure The staple legs converge, providing the additional compression, as shown in Figure
7 Step 6 Compression and Convergence (continued) 0 Starting position 1 Parallel compression 2 Convergent compression A specific spreading forceps was developed for the Large Uni-Clip staples. With the first action, the device provides compression by pulling legs together in a parallel fashion. A second, separate action can then be applied to converge the staple legs toward one another, creating additional compression. 2 65% additional compression Compression Force Convergent Compression Parallel Compression 0 1 Compression Applied Depending on bone quality and parallel compression, convergence can increase initial compression by 65%. (Data on file at Newdeal) Initial compression by tightening the legs Additional compression by convergence of the legs Optimum Compression 6
8 Tray Layout LARGE UNI-CLIP DUAL-COMPRESSION STAPLE Tray Layout ND Drill diam. 2.2mm Lg. 180mm AO attachment ND Uni-Clip drilling guide ND Uni-Clip depth gauge ND Uni-Clip staple impactor ND Uni-Clip spreading forceps ND Large Uni-Clip spreading forceps ND Large Uni-Clip impactor handle ND Large Uni-Clip impactor attachment ND Large Uni-Clip straight drilling guide ND Large Uni-Clip offset drilling guide ND Drill diam 3.0mm AO attachment 7
9 Staple Options Staple Options SND Notched Uni-Clip Width 15mm Lg 12mm SND Notched Uni-Clip Width 20mm Lg 20mm SND Uni-Clip Interaxis 20mm Length 20mm SND Uni-Clip Interaxis 25mm Length 25mm SND Uni-Clip Interaxis 25mm Length 20-25mm SND Uni-Clip Interaxis 30mm Length 27-32mm 8
10 Integra Large Uni-Clip Dual-Compression Staples Large Uni-Clip Reference Description SND Interaxis 20mm - L mm SND Interaxis 25mm - L mm SND Interaxis 25mm - L mm SND Interaxis 30mm - L mm Container Reference Description ND Large Uni-Clip container ND Large Uni-Clip container lid ND Large Uni-Clip container basis ND Large Uni-Clip container cylinder Instrumentation Reference Description ND Drill diam. 2.2mm Lg. 180mm AO attachment ND Uni-Clip drilling guide ND Uni-Clip depth gauge ND Uni-Clip staple impactor ND Uni-Clip spreading forceps ND Large Uni-Clip spreading forceps ND Large Uni-Clip impactor handle ND Large Uni-Clip impactor attachment ND Large Uni-Clip straight drilling guide ND Large Uni-Clip offset drilling guide ND (Locking system) drill diam 3.0mm AO attachment 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 Always refer to the appropriate instructions for use for complete clinical instructions. 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. 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: Newdeal SAS Immeuble Séquoia 2 n 97 allée Alexandre Borodine Parc technologique de a Porte des Alpes Saint Priest n France Uni-Clip, 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 EN
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