HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED AS AN INITIAL / FINAL REPORT BASED ON INFORMATION DISCOVERED DURING THE DEVICE EVALUATION. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE WAS VIBRATING DURING USE; THE MOTOR SPEEDS WERE ERRATIC, THE CONTROL BAR WAS LOOSE, AND THE EXTERNAL E-RING WAS MISSING FROM THE NEEDLE BEARING. THE END CAP, PLUG HARNESS, WASHER, ECCENTRIC SHAFT, SPRING SEAL, BEARINGS, RETAINING RING, SCREWS, POWER SWITCH, SWITCH MOUNT, MOTOR, EXTERNAL E-RING, RECIPROCATING ARM, AND INSULATOR WERE REPLACED, AND THE CONTROL BAR WAS ADJUSTED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY, DURING TESTING PHASE, THE UNIT WAS VIBRATING. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE MOTOR SPEEDS WERE ERRATIC. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.