FIBULINK® SYNDESMOSIS REPAIR KIT/ TI
Report
- Report Number
- 8030965-2025-08221
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- July 25, 2025
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTN
- PMA / PMN Number
- K162805
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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: ADDED: D4 (EXPIRY DATE), D10 (CONCOMITANT), H4. CORRECTED: D4 (PRIMARY UDI NUMBER). 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. MANUFACTURING SITE: ROBLING MEDICAL, INC. SUPPLIER: NA. RELEASE TO WAREHOUSE DATE: 17 DEC 2024. EXPIRATION DATE: 01 DEC 2027. 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.
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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE-DISLOCATION OF THE FIBULA WITH THE FIBULINK. AFTER FIXING THE FRACTURE WITH AN FBL PLATE, THE TIBIOFIBULAR SPACE WAS FIXED WITH PERIARTICULAR FORCEPS TO PREVENT MOVEMENT. SURGEON THEN MOVED ON TO THE FIBULINK PROCEDURE. AN IMAGE CONFIRMED THAT THE FIBULINK AND TENSIONING CAP WERE CONNECTED. THE SILVER GUIDE TUBE WAS PULLED OUTWARD TO CHECK THE LEVEL OF TENSION, BUT THE TENSIONING CAP WAS CONFIRMED TO BE FLOATING OFF THE PLATE. WHEN THE SURGEON TURNED IT FURTHER, THE PERMACORD BROKE. THE TIBIAL SCREW THAT REMAINED IN THE TIBIA WAS REMOVED WITH AN EXTRACTION SET. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT FIXATION OF THE TIBIOFIBULAR SPACE WITHIN 30MINS OF DELAY. WHEN THE FIBULINK WAS CHECKED AFTER SURGERY, IT WAS FOUND TO BE QUITE EMBEDDED IN THE TENSIONING CAP, AND IT IS THOUGHT THAT OVER-TIGHTENING HAD CAUSED THE PERMACORD TO COME INTO CONTACT WITH THE TENSIONING CAP, CAUSING IT TO BREAK. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2035256 | FIBULINK® SYNDESMOSIS REPAIR KIT/ TI | WASHER, BOLT NUT | HTN | SYNTHES GMBH | 24E019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | FGS-1300 |