G7 CURVED INSERTER THD SHAFT

Additional Manufacturer Narrative

(B)(4). THE REPORTED DEVICE HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER INSERTING THE CUP AND TAKING APART THE HANDLE, THE CURVED INSERTER THREADED SHAFT SPLIT INTO TWO PIECES. THE CUP WAS ALREADY IMPLANTED, SO THE INSTRUMENT WASN¿T NEEDED TO COMPLETE THE SURGERY. AFTER THE CASE SMALLER FRAGMENT WAS ACCIDENTALLY THROWN AWAY. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.