FIBULINK(R) 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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D6A: IMPLANT DATE WAS AN UNKNOWN DAY IN (B)(6) 2024.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE FIBULINK REMOVAL KIT. IN (B)(6) 2024, A TIBIOFIBULAR FIXATION WAS PERFORMED USING THE FIBULINK. ON (B)(6), 2025, A REMOVAL SURGERY WAS PERFORMED USING THE FIBULINK REMOVAL KIT, BUT THE NAIL COULD NOT BE COMPLETELY REMOVED. (ONLY THE TIBIAL SCREW REMAINED INSIDE THE BODY.) AFTER REMOVING THE TENSIONING CAP, AN ATTEMPT WAS MADE TO REMOVE THE TIBIAL SCREW USING A TIBIAL SCREWDRIVER, BUT THE PLACEMENT BETWEEN THE TIBIA AND FIBULA OF THE FIBULA LINK WAS NOT IN A STRAIGHT LINE AND WAS DIFFERENT IN THE ANTERIOR-POSTERIOR DIRECTION OF THE MEDIAL/LATERAL, MAKING IT IMPOSSIBLE TO CAPTURE THE TIBIAL SCREW THROUGH THE FIBULA LINK. AFTER TWISTING OFF THE PERMACORD AND REMOVING THE FIBULA LINK, THE SURGEON ATTEMPTED TO REMOVE IT USING A TIBIAL SCREW REMOVER, BUT IT DID NOT ENGAGE WITH THE TIBIAL SCREW. WHEN THE SURGEON ATTEMPTED TO REMOVE IT USING AN EXTRACTION SCREW 1.5/2.0MM, THE OUTER PART OF THE TIBIAL SCREW (THE PART THAT CONNECTS TO THE TIBIAL SCREWDRIVER) BROKE, MAKING IT COMPLETELY DIFFICULT TO REMOVE, SO THE SURGERY WAS COMPLETED WITH ONLY THE TIBIAL SCREW REMAINING INSIDE THE BODY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.