BIOBRACE

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, BB23X30, BIOBRACE REINFORCED BIOINDUCTIVE IMPLANT, 23 X 30 MM, WAS INITIALLY IMPLANTED IN A PATIENT ON (B)(6) 2023 DURING A REVISION CUFF PROCEDURE IN WHICH A REGENETEN HAD ALREADY FAILED. ON (B)(6) 2025, THE PATIENT WAS SEEN AGAIN FOR A REVISION CUFF PROCEDURE. WHEN THE DEVICE WAS REVIEWED DURING THIS PROCEDURE, THE DEVICE ¿DID NOT APPEAR INCORPORATED. IT WAS BRITTLE AND MOVED INDEPENDENT OF THE CUFF¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE WAS EXPLANTED, UNKNOWN DATE, AND NO MALFUNCTION OF THE DEVICE WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, BUT PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. A ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BASED UPON PHOTOGRAPHIC EVIDENCE, AND THE RISK DOCUMENT A POSSIBLE CAUSE OF THIS EVENT COULD BE THAT THE DEVICE WAS CRUSHED DURING SURGERY. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 1 COMPLAINT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO AVOID CRUSHING THE DEVICE. SURGEON MUST CHOOSE PROPER IMPLANT SIZE BASED ON SPECIFIC PROCEDURE AND PATIENT HISTORY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, BB23X30, BIOBRACE REINFORCED BIOINDUCTIVE IMPLANT, 23 X 30 MM, WAS INITIALLY IMPLANTED IN A PATIENT ON (B)(6) 2023 DURING A REVISION CUFF PROCEDURE IN WHICH A REGENETEN HAD ALREADY FAILED. ON (B)(6) 2025 THE PATIENT WAS SEEN AGAIN FOR A REVISION CUFF PROCEDURE. WHEN THE DEVICE WAS REVIEWED DURING THIS PROCEDURE, THE DEVICE ¿DID NOT APPEAR INCORPORATED. IT WAS BRITTLE AND MOVED INDEPENDENT OF THE CUFF¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE WAS EXPLANTED, UNKNOWN DATE, AND NO MALFUNCTION OF THE DEVICE WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.