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Patient 1
THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON (B)(6) 2020, IT WAS REPORTED THAT DURING TEST AND CALIBRATION UNIT, THE DEVICE WAS FOUND TO BE IN NEED OF REPAIR. THE DEVICE WAS SENT IN FOR PM ONLY. THE CUSTOMER RETURNED AN AIR DERMATOME DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A HOSE AND 1"/2"/3"/4" WIDTH PLATES, FOR EVALUATION. PRODUCT REVIEW OF THE AIR DERMATOME ON (B)(6) 2020 REVEALED THAT THE MOTOR SPEED WAS ERRATIC. THE CONTROL WAS IN THE CORRECT POSITION AND THE CALIBRATION WAS OUT OF SPECIFICATIONS AT ALL SETTINGS. REPAIR OF THE AIR DERMATOME HAS NOT BEEN PERFORMED BY ZIMMER BIOMET SURGICAL AS THE DEVICE IS AGED AND THE CUSTOMER WAS UNRESPONSIVE SO THE DEVICE WILL BE RETURNED TO THEM UNREPAIRED. WHILE THE RETURNED PRODUCT INVESTIGATION CONFIRMED THAT THE AIR DERMATOME REQUIRED REPAIR, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHICH COMPONENT OR COMBINATION OF COMPONENTS CAUSED THE PM TO ESCALATE TO A REPAIR. A NUMBER OF FINDINGS WERE NOTED DURING EVALUATION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT SUCH AS THE CALIBRATION BEING OUT OF SPECIFICATION AT ALL SETTINGS AND THE MOTOR RUNNING ERRATICALLY. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE DEVICE WAS NOT REPAIRED AS THE CUSTOMER DID NOT RESPOND TO THE REPAIR QUOTE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.