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Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD AND PREVIOUS REPAIR 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 REVIEWS 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 WAS NOT WORKING. THE CUSTOMER RETURNED A ZIMMER SKIN GRAFT MESHER SERIAL NUMBER (B)(4) FOR EVALUATION. (DURING) EVALUATION OF THE DEVICE ON 11 DECEMBER 2019, IT WAS NOTED THAT THE COMB WAS DAMAGED. NO TESTING COULD BE PERFORMED WITH THE MESHER DUE TO THE DAMAGED COMB. REPAIR OF THE MESHER OCCURRED THE SAME DAY AND INVOLVED REPLACING THE COMB. 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 CONFIRMED THAT THE COMB WAS DAMAGED, WHICH WOULD PREVENT THE DEVICE FROM OPERATING AS INTENDED, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE COMB TO BECOME DAMAGED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. 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.