ZIMMER AIR DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS SENT IN FOR SERVICE AS IT WAS NOT WORKING AS IT WAS BROKEN. INCONSISTENT SPEED WAS CONFIRMED DURING FINAL INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE WAS NO FURTHER INFORMATION AVAILABLE.

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 NOT STABLE, THE SWIVEL WAS LOOSE, THE RECIPROCATING ARM, SCREWS, AND HINGE WERE WORN, THE CONTROL BAR FAILED, AND THE DEVICE WAS OUT OF CALIBRATION. THE MOTOR, SLEEVE, SWIVEL, RECIPROCATING ARM, SCREWS, HINGE, CONTROL BAR, AND BEARINGS WERE REPLACED, AND THE DEVICE WAS RECALIBRATED 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 TRENDS. G2: FINLAND.