BIO MINI-REVO SUTURE ANCHOR, PRELOADED

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INSERTION OF THE BIO MINI-REVO ANCHOR, INTO THE PT'S SHOULDER, THE IMPLANT BROKE WHEN THE SURGEON ATTEMPTED TO RELEASE IT FROM THE DISPOSABLE DRIVER. THE BROKEN ANCHOR WAS REMOVED FROM THE PT WITHOUT ANY SERIOUS INJURY, ADD'L INTERVENTION OR DELAY.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: AN EVALUATION CONFIRMED BREAKAGE OF THE PRE-LOADED ANCHOR WITH THE PROXIMAL END LODGED IN THE DRIVER. APPROXIMATELY, 6MM OF THE THREADED PORTION OF BROKEN ANCHOR WAS NOT RETURNED. IN ADDITION, A VISUAL INSPECTION OF THE RETURNED PORTION OF ANCHOR FOUND IT TWISTED. THE INFORMATION FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER: PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORTANT DURING IMPLANTATION OF THE BIO MINI-REVO TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR. BREAKAGE OF THE BIO MINI-REVO IS POSSIBLE IF: THE PILOT HOLE IS NOT DRILLED TO AN ADEQUATE DEPTH. THE TAP IS NOT INSERTED TO THE PROPER DEPTH. IMPROPER ALIGNMENT OF ANCHOR TO PILOT HOLE. LOOSE OR NON-SECURE ANCHOR ON DRIVER. IT IS NOT USED WITH A BIO MINI-REVO DRILL GUIDE. THE ANCHOR INSERTER IS USED FOR PRYING. THE BIO MINI-REVO IMPLANT IS ADVANCED TOO DEEP. THE CUSTOMER WILL BE PROVIDED THIS INFORMATION.