HANDPIECE, ELECTRIC DERMATOME

Additional Manufacturer Narrative

THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN CHINA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT OUTSIDE OF SURGERY DURING TESTING THE MOTOR WAS JERKY, HAD A DELAY AND RUNS AT LOW SPEED. THE HOSPITAL REPLACED THE MOTOR BY ITSELF TO SOLVE THE PROBLEM. THERE WAS NO PATIENT IMPACT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.