ALLIANCE GLENOID MODULAR CENTER POST REAMER

Additional Manufacturer Narrative

(B)(4). H6: PROPOSED CODE: MECHANICAL (G04) - DRILL THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT UPON ROUTINE INSPECTION AFTER THE INSTRUMENTS CAME THROUGH THE WASHER IT WAS NOTED THAT THE TIP OF THE REAMER HAD CRACKS IN IT AND NEEDED REPLACEMENTS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.