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Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI: (B)(4). THE DEVICE HISTORY RECORD FOR ZIMMER SKIN GRAFT MESHER SERIAL NUMBER (B)(4) WERE REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH THE DEVICE. THE RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 13 DECEMBER 2019, IT WAS REPORTED THAT A MESHER HAD A DAMAGED BASE AND THAT THE MECHANISM WAS DIFFICULT TO OPEN. THE CUSTOMER RETURNED A ZIMMER SKIN GRAFT MESHER SERIAL NUMBER (B)(4) AS WELL AS 1.5:1 CUTTER SERIAL NUMBER (B)(4) FOR EVALUATION. EVALUATION OF THE DEVICE ON 11 DECEMBER 2019 NOTED THAT THE COMB WAS DAMAGED AT THE HANDLE END AND THAT THERE WAS A MISSING RATCHET SCREW ON THE RATCHET. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE HANDLE WAS DISASSEMBLED AND NOT LUBRICATED PROPERLY. NONE OF THE PRETESTS COULD BE PERFORMED DUE TO THE DAMAGED COMB. REVIEW OF THE RETURNED CUTTER NOTED THAT IT PRODUCED A PASSING TEST MESH. REPAIR OF THE MESHER OCCURRED THE SAME DAY AND INVOLVED REPLACING THE COMB AND THE MISSING RATCHET SCREW AS WELL AS RELUBRICATING AND REASSEMBLING THE RATCHET. THE TECHNICIAN THEN RECALIBRATED THE DEVICE AND VERIFIED THAT IT WAS FUNCTIONING AS INTENDED. THE MESHER WAS THEN RETURNED TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. WHILE THE SERVICE TECHNICIAN FOUND THAT THE COMB WAS DAMAGED AND THERE WAS A MISSING RATCHET SCREW, THERE WAS NO FINDINGS REFERRING TO THE BASE OF THE DEVICE BEING DAMAGED NOR WAS THERE MENTION OF THE DEVICE BEING DIFFICULT TO OPEN. AS SUCH, A SPECIFIC CAUSE THE REPORTED EVENTS CANNOT BE DETERMINED. DURING EVALUATION OF THE DEVICE THOUGH, IT WAS FOUND THAT THE RATCHET HANDLE HAD BEEN IMPROPERLY LUBRICATED AND DISASSEMBLED. THE INSTRUCTIONS FOR USE FOR THE ZIMMER SKIN GRAFT MESHER (ZIMMER SKIN GRAFT MESHER INSTRUCTION MANUAL) PROVIDES INSTRUCTIONS ON HOW TO PROPERLY ASSEMBLE AND DISASSEMBLE THE DEVICE AS WELL AS HOW TO LUBRICATE THE RATCHET ON PAGE 7. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THAT THERE ARE NO FURTHER ACTIONS NEEDED AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.