BIO MINI-REVO SUTURE ANCHOR, PRELOADED

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: THE BIO MINI-REVO IMPLANT WAS RECEIVED FOR EVALUATION WITHOUT THE BROKEN PORTION. DURING A VISUAL EXAMINATION OF THE DEVICE, THE ANCHOR WAS FOUND BROKEN INSIDE THE DRIVER. THE INFORMATION FOR USE (IFU) PROVIDES USER INFORMATION REGARDING BREAKAGE. 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.

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING A SHOULDER ARTHROSCOPY WITH LABERAL REPAIR, THIS SUTURE ANCHOR IMPLANT BROKE OFF AT THE INSERTER AND WAS NOT RETRIEVED. THE SURGERY WAS COMPLETED WITH THE USE OF TWO ADDITIONAL ANCHORS AND THERE WAS NO REPORT OF INJURY OR SURGICAL DELAY.