HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE MOTOR WAS CORRODED AND THE SPEEDS WERE NOT STABLE, AND THE RECIPROCATING ARM, SCREWS, AND EXTERNAL E-RING WERE WORN. THE MOTOR, RECIPROCATING ARM, SCREWS, AND EXTERNAL E-RING WERE REPLACED 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 REPORTED 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. E1 TELEPHONE NUMBER: (B)(6). G2 COUNTRY: QATAR.

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE MOTOR SPEEDS WERE NOT STABLE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.