FIBULINK SYNDESMOSIS REPAIR KIT TI

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 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

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. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE LATERAL END OF THE TIBIA SCREW BROKE DURING FIBULINK REMOVAL SURGERY. THE TENSIONING CAP AND FIBULA LINK WERE REMOVED SMOOTHLY, BUT THE TIBIA SCREW WAS NOT EASILY ATTACHED TO THE EXTRACTION INSTRUMENT, SO THE SURGEON ATTEMPTED TO REMOVE IT USING THE EXTRACTION-SCREW. THE SURGEON WAS ABLE TO CONNECT THE EXTRACTION SCREW TO THE TIBIAL SCREW, AND THE TIBIAL SCREW WAS FIRMLY FIXED TO THE BONE. THE TIBIAL SCREW WOULD NORMALLY BE POSSIBLE TO REMOVE IT BY TURNING COUNTERCLOCKWISE, BUT IT WOULD NOT COME OUT. AS A RESULT OF CONTINUING TO TURN THE EXTRACTION-SCREW COUNTERCLOCKWISE, THE EXTRACTION-SCREW WENT FURTHER INTO THE TIBIAL SCREW, AND THE LATERAL PART OF THE TIBIAL SCREW, UNABLE TO WITHSTAND THIS STATE, BROKE. BECAUSE THE PATIENT HAD BEEN INFORMED IN ADVANCE THAT THE IMPLANT MIGHT NOT BE ABLE TO BE REMOVED, THE SURGERY WAS COMPLETED WITH THE IMPLANT LEFT IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY.