BIO MINI-REVO SUTURE ANCHOR

Description of Event or Problem

IT WAS REPORTED THAT DURING INSERTION OF THIS SUTURE ANCHOR IN THE PT'S LEFT SHOULDER, THE IMPLANT BROKE AND THE DETACHED PORTION REMAINS IN THE PT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR AND NO ADDITIONAL TREATMENT IS EXPECTED.

Additional Manufacturer Narrative

THE ANCHOR WAS RECEIVED FOR INVESTIGATION AND THE REPORTED PROBLEM WAS VERIFIED. THE INSTRUCTIONS FOR USE PROVIDED TO THE CUSTOMER WITH THE PRODUCT INFORMS THE USER: NOTE: THE MINI-REVO IMPLANT MUST BE SEATED SECURELY AND FIRMLY. IF THE IMPLANT IS LOOSE OR WOBBLES ON THE END OF THE DRIVER, DEPRESS THE SUTURE RETENTION SLEEVE AND RE-TIGHTEN THE SUTURE. NOTE: PROPER ORIENTATION AND ALIGNMENT OF INSTRUMENTS IS IMPORTANT DURING IMPLANTATION OF THE MINI-REVO TO MINIMIZE POSSIBLE BREAKAGE OF THE ANCHOR. BREAKAGE OF THE IMPLANT IS POSSIBLE IF: THE PILOT HOLE IS NOT DRILLED AND TAPPED TO AN ADEQUATE DEPTH, IMPROPER ALIGNMENT OF ANCHOR TO PILOT HOLE OR LOOSE OR NON-SECURE ANCHOR ON DRIVER.