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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 REVIEWS FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 13 JANUARY 2020, IT WAS REPORTED THAT THE INTERNAL PLASTIC ROTOR ON A DERMATOME WAS LOOSE AND WOULD NOT WORK. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) FOR EVALUATION. EVALUATION OF THE DEVICE BY ZIMMER (B)(4) ON 13 JANUARY 2020 NOTED THAT THE OSCILLATOR WAS BROKEN AND LOOSE INSIDE OF THE MACHINED HEAD, THE HEAD WAS WORN, AND THAT THE DEPTH BAR HAD EXCESSIVE SIDE PLAY. THE DEVICE WAS FORWARDED TO ZIMMER (B)(4) FOR FURTHER EVALUATION AND REPAIR. EVALUATION OF THE DEVICE BY ZIMMER (B)(4) ON 22 JANUARY 2020 AND FOUND THAT THE MOTOR RAN BELOW MOTOR SPEED SPECIFICATIONS, AND THAT THE DEVICE WAS OUT OF CALIBRATION AT ALL FOUR SETTINGS. UPON FURTHER EVALUATION, IT WAS FOUND THAT THE NECKPIECE WAS BROKEN AND THAT THE MOTOR, MULTIPLE BEARINGS, O-RING, SEAL, RECIPROCATING ARM, EXTERNAL E-RING, MACHINED HEAD, AND THE DIE CAST LEVER WERE ALSO DEFECTIVE. REPAIR OF THE DERMATOME OCCURRED ON 31 JANUARY 2020 AND INVOLVED REPLACING THE MOTOR, MULTIPLE BEARINGS, O-RING, SEAL, RECIPROCATING ARM, NECKPIECE ASSEMBLY, EXTERNAL E-RING, MACHINED HEAD, AND DIE CAST LEVER. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DEVICE 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 DERMATOME HAD A BROKEN RECIPROCATING ARM, WHICH WOULD CAUSE THE DEVICE TO NOT PRODUCE THE MOTOR SPEED NECESSARY TO OSCILLATE THE BLADE PROPERLY, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE DAMAGE TO THE RECIPROCATING ARM. 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 PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.