N
Patient 1
THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE DEVICE HISTORY RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS 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 (B)(6) 2019, IT WAS REPORTED THAT A DERMATOME NEEDED TO BE REPAIRED. A ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS ALREADY AT A ZIMMER FACILITY AND WAS AVAILABLE FOR EVALUATION. EVALUATION OF THE DEVICE ON (B)(6) 2019 NOTED THAT THE DEVICE WAS OUT OF CALIBRATION AT THE ZERO SETTING AND WAS OUTSIDE OF MOTOR SPEED SPECIFICATIONS AND RAN ERRATICALLY. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE MACHINED HEAD AND THE CONTROL BAR WERE DAMAGED. REPAIR OF THE DERMATOME OCCURRED THE SAME DAY AND INVOLVED REPLACING THE MACHINED HEAD, CONTROL BAR, MULTIPLE BEARINGS, MOTOR, SWIVEL, AND THE POPPET ASSEMBLY. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DERMATOME WAS FUNCTIONING AS INTENDED, THEN RETURNED THE DEVICE TO THE CUSTOMER WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. WHILE THE SERVICE TECHNICIAN FOUND THAT THE DEVICE RAN BELOW MOTOR SPEED SPECIFICATIONS, HAD A DEFECTIVE CONTROL BAR AND MACHINED HEAD, AND WAS OUT OF CALIBRATION SPECIFICATIONS, ALL FAILURES THAT WOULD REQUIRE SERVICE IN ORDER TO RESOLVE, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THESE FAILURE WITH THE DEVICE. AS SUCH, A SPECIFIC 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.