The Flower Four Corner Fusion Plate

Transcription

1 The Flower Four Corner Fusion Plate PROCEDURE GUIDE

2 The Flower Upper Extremity Application PROXIMAL HUMERUS PLATE SMALL BONE PLATES FOUR CORNER FUSION PLATE ANATOMIC DISTAL RADIUS PLATE INDICATIONS FOR USE: The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, ventral, dorsal and orthogonal application. 2 The Flower Four Corner Fusion Plate Procedure Guide

3 The Flower Four Corner Fusion Plate Product Rationale The Flower Four Corner Fusion Plate (Mediocarpal Plate) Construct consists of low profile circular neutralization plates designed to best fit the unique anatomical requirements of the carpal bones while providing the stability needed for a predictable joint fusion. The Flower Four Corner Fusion Plate combines fast and efficient joint stabilization, bone graft visualization, and a low profile for ease of use. The Flower Four Corner Fusion Plate allows for the use of variable angle locking and non-locking screws which all sit flush in the screw holes of the plate. The Flower Four Corner Fusion Plate Design Features PLATE RATIONALE Low profile circular plates with smooth surface and rounded edges SURGICAL BENEFIT Reduced soft tissue irritation and flexible positioning Two plate diameters (11.5mm and 13.3mm) Adaptable to specific anatomy Plates accept 1.5mm, 2.0mm and 2.4mm locking and non-locking screws Provides multiple screw options for operative management The patented Flower locking mechanism and Allows surgeon to aim and lock the screw as variable angle locking screw holes allow for needed without the need for special drill +/- 10 of freedom guides The Flower Four Corner Fusion Plate Procedure Guide 3

4 The Flower Four Corner Fusion Plate Surgical Strategy Step 1 Reaming the Fusion Site a. First use Flower K-Wires (KWK 001) to provisionally stabilize the carpal bones to be fused. b. The Mediocarpal Reamer (FIS 204) is available in one size that creates the appropriate recess for either size of the Flower Four Corner Fusion Plate. c. Place the sharp tip of the reamer on the proximal-medial pole of the hamate and apply light pressure to create a recess for the plate. d. Ideal reaming allows the plate to sit just palmar to the dorsal surface. e. The joints between the four bones to be fused are now cleared of cartilage and cortical bone. Cancellous bone graft can be applied to fill the joint interspace. Step 2 Plate Placement a. A Plate Trial (FIS 013) is available to properly size the required plate before opening the sterile packaged plate. Step 3 Drill Holes and Screw Placement a. 2.4mm variable angle locking or non-locking screws are recommended for the Flower Four Corner Fusion Plate Construct. Variable angle non-locking screws will lag the plate to the bone. b. Using a 1.8mm Drill Bit (DBK 024), pilot holes are created. Use the locking end of the Drill Guide for all locking holes in the plate. 4 The Flower Four Corner Fusion Plate Procedure Guide

5 The Flower Four Corner Fusion Plate Surgical Strategy Step 4 Placement of Locking Screws a. The Depth Gauge is part of the K-Wire Kit (KWK 001). b.the Depth Gauge must be fully seated into the locking hole before the hook probe is advanced into the pilot hole. c. The hook of the Depth Gauge is engaged on the opposite cortex of the pilot hole and the pilot hole depth can be read off the distal end of the slider. d. Insert the locking screws into Flower locking holes using the Flower Torque Limiting Screwdriver that is part of the Flower K-Wire Kit (KWK 001). The torque limiting feature does not need to be engaged to guarantee sufficient locking. Step 5 Placement of Non-Locking Screws a. Non-locking screws are placed repeating the steps above for locking screws. b. The torque limiting feature must not to be engaged when placing non-locking screws. The screws are fully seated once they are flush with the top of the locking hole. Step 6 The Final Construct The Flower Four Corner Fusion Plate accommodates the unique anatomical requirements of the carpus while providing stability needed for a predictable joint fusion. The low profile circular plates and flush fitting screws reduce implant prominence and limit soft tissue irritation. The Flower Four Corner Fusion Plate Procedure Guide 5

6 The Flower Four Corner Fusion Plate Implant Selection VARIABLE ANGLE LOCKING SCREWS Screw Diameters Product Description Lengths 1.5mm 1.5mm Variable Angle Locking Screw 6mm-20mm 2.0mm 2.0mm Variable Angle Locking Screw 6mm-22mm 2.4mm 2.4mm Variable Angle Locking Screw 6mm-22mm 4 VARIABLE ANGLE NON-LOCKING SCREWS Screw Diameters Product Description Lengths 1.5mm 1.5mm Variable Angle Non-Locking Screw 6mm-20mm 2.0mm 2.0mm Variable Angle Non-Locking Screw 6mm-22mm 2.4mm 2.4mm Variable Angle Non-Locking Screw 6mm-22mm 4 FLOWER FOUR CORNER FUSION PLATE (MEDIOCARPAL PLATE) PORTFOLIO Part # Product Description Diameter FMP 211 Four Corner Fusion Plate, 5 Holes 11.5mm FMP 213 Four Corner Fusion Plate, 7 Holes 13.3mm 4 6 The Flower Four Corner Fusion Plate Procedure Guide

7 TThe Flower Four Corner Fusion Plate Single-Use Instrument Overview FOUR CORNER FUSION PLATE TRIALS Part # Contents of Kit FIS 013 Four Corner Fusion Plate Trials, 1.5mm K-WIRE KIT (KWK 001) Kit Size Contents of Kit K-Wire Kit, Torque Wrench (Small), Depth Gauge (Small) Small K-Wire, D: 0.8mm DRILL BIT KITS Part # DBK 015 DBK 020 DBK 024 Contents of Kit Drill Bit, D: 1.1mm, Drill Guide Drill Bit, D: 1.5mm, Drill Guide Drill Bit, D: 1.8mm, Drill Guide REAMER Part # FIS 204 Contents of Kit Reamer for Four Corner Fusion Plate (Mediocarpal), D:17.5mm The Flower Four Corner Fusion Plate Procedure Guide 7

8 FlowerCube : Schedule. Treat. Turn. Schedule Case Sooner. (Ready-for-Surgery ) Treat Confidently. (Sterile & Disposable) Turn OR Faster. (FlowerCube) No cleaning and sterilization FlowerCube is always ready to complete the case No time consuming set drop off Instrument kits are always complete Drill bits are always sharp Guaranteed sterility FlowerCube is always ready for the next surgery No delay with back to back cases Enough sterile inventory for multiple cases Flower Orthopedics Corporation 100 Witmer Road Suite 280 Horsham, PA T: F: FOCPG-UE-004 RevA 5/15