FIBULINK SYNDESMOSIS REPAIR KIT TI

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT THE FIBULINK SYNDESMOSIS REPAIR KIT TI WAS INVOLVED IN A REPORTED INTRAOPERATIVE EVENT. DURING AN OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE FOR AN ANKLE FRACTURE, THE SURGEON ENCOUNTERED DIFFICULTY WHEN THE STANDARD TENSIONING CAP PENETRATED THE DISTAL CONVENTIONAL HOLE OF THE DFP SHAFT AND BEGAN TO SPIN FREELY. ATTEMPTS TO RESOLVE THE ISSUE INCLUDED USING A WASHER AND SUBSEQUENTLY A LONGER TENSIONING CAP, WHICH ULTIMATELY ALLOWED THE PROCEDURE TO BE COMPLETED, ALBEIT WITH A DELAY OF APPROXIMATELY 30 MINUTES. THE EVENT WAS NOTED AS THE SECOND OCCURRENCE OF A TENSIONING CAP PENETRATING A CONVENTIONAL HOLE, WITH SUSPICION THAT PRIOR USE OF A CORTEX SCREW TO POSITION THE PLATE MAY HAVE CONTRIBUTED TO HOLE DEFORMATION. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS AS A RESULT OF THIS EVENT.

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. H11 ADDITIONAL NARRATIVE: H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY REVIEW (DHR): PART # FGS-1100. LOT # 24E019. RELEASE TO WAREHOUSE DATE: 17 DEC 2024. EXPIRATION DATE: 01 DEC 2027. MANUFACTURING SITE: ROBLING MEDICAL, INC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.