STRAIGHT EXACT BROACH HANDLE

Description of Event or Problem

IT WAS REPORTED THAT DURING BROACHING THE RASP HANDLE BROKE. NO MISSING PIECES WERE IDENTIFIED, THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE THAT WAS ALREADY OPENED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN, EVENT OCCURRED IN CANADA. THE 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.