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Patient 1
THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON (B)(6) 2019, IT WAS REPORTED THAT THE CARRIER WOULD NOT FIT INTO THE MESHER. THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (SN (B)(4)), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 3:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A RATCHET HANDLE, FOR EVALUATION. PRODUCT REVIEW OF THE SKIN GRAFT MESHER BY FLEXTRONICS ON (B)(6) 2020 REVEALED THE UNIT WAS OUT OF CALIBRATION. THE COMB AND COMB SPRINGS WERE DAMAGED, A BEARING WAS LOOSE, A SCREW WAS WORN, AND THE STABILIZER FEET WERE DAMAGED. THE TEST MESH USING THE CUSTOMER?S MESHER AND RATCHET DID NOT CREATE A PASSING MESH. A CUTTER (3:1 1512465) WAS RETURNED TO FLEXTRONICS AND FOUND TO BE DEFECTIVE. A RATCHET WAS RETURNED AND PASSED VISUAL INSPECTION. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY FLEXTRONICS ON (B)(6) 2020 WHICH INCLUDED REPLACEMENT OF THE COMB (ITEM #: 0600181044, LOT # 64349426), COMB SPRINGS (ITEM #:06001810446, LOT # 63138643), SCREW (ITEM # 06001000134, LOT # 63092218), STABILIZER FEET (ITEM # 06001600158, LOT # 63339482), AND BEARINGS (ITEM # 06001810458, LOT # 64025336). THE UNIT WAS ALSO RECALIBRATED. SKIN GRAFT MESHER, SERIAL NUMBER ((B)(4)), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE CUTTER WAS NOT REPAIRED AND WAS RETURNED TO THE CUSTOMER. IT WAS DETERMINED THAT THE CAUSE OF THE CARRIER NOT FITTING IN THE MESHER WAS DUE TO THE DEVICE BEING OUT OF CALIBRATION. HOWEVER, IT IS UNKNOWN HOW THE DEVICE BECAME OUT OF CALIBRATION. THEREFORE, A SPECIFIC ROOT CAUSE 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 (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.