MG BONE SCREW DRILL 3.2MMDIA

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. H6: MECHANICAL (G04) - DRILL. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A DRILL BIT FRACTURED. THE SURGICAL TECHNIQUE WAS UTILIZED. NO PIECES FELL INSIDE THE PATIENT. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.