HANDPIECE, ELECTRIC DERMATOME

Description of Event or Problem

IT WAS REPORTED AN UNKNOWN TIME; THE DEVICE WAS OUT OF ORDER. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETED; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN FRANCE. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE MOTOR SPEEDS WERE UNSTABLE, THE POWER CABLE AND RETAINING RING WERE DAMAGED, AND THE ECCENTRIC SHAFT AND SCREWS WERE WORN. THE MOTOR, PLUG HARNESS, RETAINING RING, ECCENTRIC SHAFT, AND SCREWS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.