SACROFUSE

Description of Event or Problem

ON (B)(6) 2024, A SURGERY TOOK PLACE IN WHICH A SACRIX INSERTER'S TIPS BROKE OFF. THIS IS LIKELY DUE TO A DOCTOR PERFORMING A REVISION AND ATTEMPTING TO USE THE INSERTER TO REMOVE THE SCREW THAT HAS BEEN SURROUNDED BY BONY GROWTH. THIS GROWTH INCREASES THE FORCE REQUIRED TO REMOVE THE SCREW AND RESULTED IN THE BREAKING OF THE TIPS. THIS DID NOT RESULT IN PATIENT HARM AND SURGERY WAS COMPLETED.

Additional Manufacturer Narrative

DURING REVISIONS, BONY GROWTH GREATLY INCREASES THE TORQUE REQUIRED TO TURN THE SCREW. THE INSERTER TIPS CANNOT HANDLE THIS INCREASED FORCE AND, THEREFORE, BREAK OFF.