FIBULINK SYNDESMOSIS REPAIR KIT TI

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY USING FIBULINK FOR ANKLE FRACTURES. A DFP LATERAL 5-HOLE PLATE WAS USED, AND THE FIBULINK WAS INSERTED THROUGH THE CONVENTIONAL HOLE OF THE LCP COMBINATION HOLE, THE SECOND HOLE FROM THE DISTAL END. DUE TO THE POSITIONS OF THE FIBULA AND TIBIA, THE TIBIAL SCREW WAS INSERTED AT A STRONG OBLIQUE ANGLE, AND THE TENSIONING KNOB CAME OFF WHILE PRESSURE WAS BEING APPLIED TO THE TENSIONING CAP. WHEN THE SURGEON LOOKED CLOSELY AT THE SURGICAL FIELD, HE NOTICED THAT THE POSTERIOR PART OF THE HEAD OF THE TENSIONING CAP HAD PENETRATED THROUGH THE CONVENTIONAL HOLE AND WAS IN CONTACT WITH THE BONE. IT WAS DETERMINED THAT SUFFICIENT PRESSURE WAS APPLIED, AND THE GUIDE TUBE WAS REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ALTHOUGH THE TENSIONING CAP NORMALLY DOES NOT PENETRATE THROUGH THE SCREW HOLE, IT WAS QUESTIONED AT WHAT STEEP OBLIQUE ANGLE THE CAP MIGHT ACCIDENTALLY PENETRATE, AND WHETHER IT IS BETTER TO USE A WASHER EVEN WHEN A PLATE IS USED. NO FURTHER INFORMATION IS AVAILABLE.

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.

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. 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: PART # FGS-1100, SYNTHES LOT # 24E013, SUPPLIER LOT # 24E013, RELEASE TO WAREHOUSE DATE: 06. AUG .2024, EXPIRATION DATE: 01. AUG. 2027, SUPPLIER: (B)(4). NO NCR'S GENERATED DURING PRODUCTION. DHR RESULT RETRIEVED FROM (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.