MetaCun DuoMetaCun. Midfoot Fusion Locking Plate System. Surgical Technique and Ordering Information

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1 MetaCun DuoMetaCun Midfoot Fusion Locking Plate System Surgical Technique and Ordering Information

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3 Table of contents Table of contents Description... 4 Indications for use...5 Contraindications...5 Surgical Technique... 6 Incision...6 Plate selection...7 Fixing with locking screws...9 Insertion of the proximal locking screw...10 Wound closure...10 Case studies Ordering Information Implants...13 Instruments

4 Description Description The MetaFix MetaCun and DuoMetaCun locking osteosynthesis plates are made of Titanium alloy TiAl6V4 ELI (ISO ). The anatomically shaped plates may be used for various fracture or fusion indications of the midfoot. The MetaFix MetaCun plate is available in 4 lengths and has 2 threaded and 2 K-wire holes. The DuoMetaCun plates has 4 threaded and 4 K-wire holes. The plates are offered as small and medium variants, each in the lenghts of 23 mm and 25 mm. The holes for the K-wire in the MetaFix MetaCun and DuoMetaCun plates are angulated allowing the fixation with crossing K-wires. This is used for temporary fixation of the osteotomy and simultaneous fixation of the plate (Figure 1). Both plate types are fixed bicorticaly onto the bone with the MetaFix LS (Locking Screws) Ø 3.5 mm. Developed together with Dr. med. J. Walpert, Klinik Fleetinsel Hamburg. 4

5 Description XX Indications for use The Merete Locking Bone Plate System (MetaCun -, DuoMetaCun ) can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusions and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The Merete Locking Screws (Ø 3.0 mm and Ø 3.5 mm) are intended to be used in combination with Merete Locking plates for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone. XX Contraindications Osteoarthritis Primary chronical Polyarthritis Osteoporotic bone Figure 1 Crossing K-wires fix the plate temporarily onto the bone as well as the osteotomy 5

6 Surgical Technique MetaCun / DuoMetaCun Surgical Technique The following is a non-specific technique detailing the steps in fusing certain joints located in the midfoot. Due to the variation of the joint and the varying arthritic joint degeneration between patients, it is up to surgeons preference of how to best utilize the Merete plates for the specific patient. XX Incision Surgeon makes a dorsal incision to gain access to the midfoot, after verification under Flouro/Xray of the desired joint(s) for fusion. The surgeon should take care to protect any overlying neurovascular structures. Figure 2 Incision Surgeon then gains adequate exposure to prepare the specified midfoot joints for fusion, removing all remaining articular cartilage between the joint surfaces. This can be accomplished manually or by using power rongeurs, burrs, sagittal saw, K-wires to penetrate the articular surface, for fusion. This is strictly the surgeons choice, but the joint surfaces must be properly prepared before fixation is completed. Figure 3 Presentation of the joint surfaces 6

7 Surgical Technique The stiffened joints have to be released and the articular cartilage removed carefully. It is followed by a manual positioning and checking of the position. Osteophyte and periarticular bone attachments are removed with a rongeur. Figure 4 Prepared joint surface XX Plate selection Surgeon may select from 4 different lengths 2 Hole MetaFix MetaCun Plates or 4 different sizes 4 Hole MetaFix DuoMetaCun TM plates depending on the midfoot joints to be fused. Figure 5 Plate selection 7

8 Surgical Technique Figure 6 Bending of the MetaCun plate Note: The plate can be bent with the bending instruments (Ref. FH10902). When using the bending instruments, the following guidelines should be considered: Ensure that the threaded holes are not disorted during bending. Plates should only be bent in one direction. Do not re-bend plates. Surgeon manually places the MetaFix MetaCun or DuoMetaCun plate across the selected joint fusion site(s). Surgeon should make both a visual decision of the plate placement and a Flouro/Xray picture to assure the plate placement and size will sufficiently bridge the fusion surface and not allow the screw fixation to be in or too close to the joints. Figure 7 Temporary fixation of the plate 8

9 Surgical Technique XX Fixing with locking screws The plate is first screwed on distally. 1. Screwing in the drill guide Ø 2.5 mm (Ref. FH10046) 2. Bicortical drilling with the drill Ø 2.5 mm (Ref. FH10004) 3. Removing the drill guide and measuring the screw length with the depth gauge (Ref. AC00007) 4. Screwing in the MetaFix LS Locking Screw Ø 3.5 mm, corresponding to the selected length Figure 8 Screwing in the drill guide Figure 9 Bicortical drilling Figure 10 Measuring the screw length Figure 11 Screwing in the distal screw Note: Placement of Locking Screws The screw and the screwdriver should be exactly aligned with the axis of the screw hole. The screw should easily thread and lock into the plate. Do not use much force when tightening the screws. If resistance is met, slightly back out screw, realign screw and screw driver and turn the screw in again. The screw head should end up flush to the plate. For screw length measurements indicated with odd numbers, round up to ensure bi-cortical placement of the locking screw. 9

10 Surgical Technique XX Insertion of the proximal locking screw 5. Screwing in the drill guide Ø 2.5 mm (Ref. FH10046) 6. Remove the proximal K-wire 7. Bicortical drilling with the drill Ø 2.5 mm (Ref. FH10004) applying manual compression 8. Remove the drill guide and measure the screw length with the depth gauge (Ref. AC00007) Screwing in the MetaFix LS Locking Screw Ø 3.5 mm, corresponding to the selected length and wound closure Figure Screwing in the drill guide 8. Figure 13 Removing the proximal K-wire Figure 14 Bicortical drilling Figure 15 Measuring the length for the proximal screw lenght 9+10 XX Wound closure Figure 16 Close the wound using the standard technique. Tightening the screws 10

11 Case studies Case studies standing 11

12 Case studies standing 12

13 Ordering Information MetaCun / DuoMetaCun Ordering Information XX Implants For the implantation of the MetaFix MetaCun and DuoMetaCun plates, the MetaFix basic instruments are used. In addition to the system, we offer the MetaFix Upgrade Kit (Ref. FH10700). Besides the storage possibility of up to 3 plate systems of the MetaFix family, this kit contains an additional bending instrument (Ref. FH10902). It also holds MetaFix TM LS Locking Screws Ø 3.5 mm in the lenghts ranging 34 to 48 mm (Ref. FH FH35048). MetaCun plate non-sterile Size Ref. 21 FH FH FH FH03027 DuoMetaCun plate non-sterile Size S 23 S 25 M 23 Ref. FH06023 FH06025 FH07023 S / M M 25 FH mm / 25 mm 13

14 Ordering Information MetaFix LS Locking Screws non-sterile Length MetaFix TM LS Ø 3.0 mm MetaFix TM LS Ø 3.5 mm 12 mm FH30012 FH mm FH30014 FH mm FH30016 FH mm FH30018 FH mm FH30020 FH mm FH30022 FH mm FH30024 FH mm FH30026 FH mm FH30028 FH mm FH30030 FH mm FH30032 FH mm - FH35034* 36 mm - FH35036* 38 mm - FH35038* 40 mm - FH35040* 44 mm - FH35044* 48 mm - FH35048* * contained in MetaFix TM Upgrade Kit MetaFix Upgrade Kit (Ref. FH10700) MetaFix available for tray (Ref. FH10450) Providing up to three more plates of the MetaFix familiy (MetaFix MetaCun, MetaFix DuoMetaCun, MetaFix OpenWedge) Includes additional MetaFix LS Ø 3.5 mm Comes with an extra bending instrument (Ref. FH10700) 14

15 Ordering Information XX Instruments MetaFix I tray Description MetaFix tray with Instruments without Implants MetaFix case with instruments and implants: 10 MetaFix I Plate (1 plate a Size, left and right) 6 MetaFix BLP Plate (1 plate a Size, left and right) 22 MetaFix LS Screws Ø 3.0 mm (2 Screws a Length) 22 MetaFix LS Screws Ø 3.5 mm (2 Screws a Length) Ref. FH10400 FH

16 Ordering Information MetaFix tray (Ref. FH10450) pcs. Description Ref. 2 Drill bit Ø 2.0 mm, L: 150 mm, AO-coupling FH Drill bit Ø 2.5 mm, L: 150 mm, AO-coupling FH Bending instrument I FH Bending instrument II FH Drill guide Ø 2.0 mm FH Drill guide Ø 2.5 mm FH K-wire Ø 1.4 mm, L: 150 mm, trocar CK14015* 4 K-wire Ø 1.4 mm, L: 70 mm, trocar CK14007* 1 Screwsdriver SW 2.5 mm, L: 175 mm FH Depth gauge 0 mm - 40 mm AC00007 *packing unit 10 pieces Description MetaFix Upgrade Kit without Implants Ref. FH10700 MetaFix Upgrade Kit with Implants FH

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20 Distributed by: Merete Medical GmbH Alt-Lankwitz Berlin, Germany Tel.: +49 (0) Fax: +49 (0) Crotty Lane - Suite 118 New York International Plaza Stewart International Airport (SWF) New Windsor, NY (USA) Phone: Fax: service@mereteusa.com Internet: HDB Manufactured by: