HANDPIECE, ELECTRIC DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, THE OPERATING SOUND FROZE DURING THE PROCEDURE AND REFUSED TO WORK LATER. TESTED WITH ANOTHER POWER SUPPLY. MACHINE BROKEN. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT IMPACT. IT IS UNKNOWN IF A DELAY OCCURRED. DUE DILIGENCE IS COMPLETE.

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE MOTOR SPEEDS WERE UNSTABLE, THE MACHINED HEAD, SPRING PIN, BALL PLUNGER, LEVER, AND CABLE WERE DAMAGED (NO EXPOSED METAL WIRING), AND THE RECIPROCATING ARM AND SCREWS WERE WORN. THE MOTOR, RECIPROCATING ARM, PLUG HARNESS, MACHINED HEAD, SPRING PIN, BALL PLUNGER, LEVER, AND SCREWS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. G2: FOREIGN - EVENT OCCURRED IN FINLAND.