FIBULINK® SYNDESMOSIS REPAIR KIT/SS

Description of Event or Problem

IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE FIBULINK WAS DEFECTIVE. SUTURE BRIDGE BROKE ALMOST IMMEDIATELY AFTER TENSIONING PROCESS BEGAN. ALL STEPS OF THE SURGICAL TECHNIQUE GUIDE WERE FOLLOWED. THERE WAS NO SURGICAL DELAY. THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE H4 DEVICE HISTORY PART # FGS-1000-US SYNTHES LOT # 22E008 SUPPLIER LOT # 22E008 RELEASE TO WAREHOUSE DATE: 09 MAY 2022 SUPPLIER: (B)(6). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.