FIBULINK FGS-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00863176000300), received between Aug 11, 2020 and Aug 26, 2026 — classified as 42 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (58 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458266 ↗
• MalfunctionAug 26, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458217 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED DURING THE PROCEDURE ON (B)(6) 2026 THE STEP DRILL BIT BROKE IN THE PATIENT¿S TIBIA. THE SURGEON MANAGED TO REMOVE THE BROKEN PIECE BY MALLETING IT THROUGH THE LATERAL SIDE OF THE PATIENT¿S LEG. IT WAS NOTED THE PROCEDURE TIME WAS SIGNIFICANTLY INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746446 ↗
• InjuryJan 27, 2026Break

  IT WAS REPORTED THAT THE DRILL-BIT FOR THE FIBULINK SNAPPED WHILE DRILLING. PATIENT WILL HAVE TO COME BACK FOR ANOTHER SURGERY TO GET HARDWARE TAKEN OUT. 45MIN SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 24188803 ↗
• MalfunctionJan 5, 2026Difficult to Advance

  IT WAS REPORTED ON AN UNKNOWN DATE, THEY TRIED USING THE FIBULINK SYSTEM IN A CASE AND THE FOLLOWING OCCURRED. FIRST TRY THE FIBULINK DID NOT DEPLOY AND THE GOLD AND SILVER TUBES CAME OUT. SECOND AND THIRD TIME - THE SILVER AND GOLD TUBES PULLED OUT WHILE TRYING TO DEPLOY THE SUTURE. SURGICAL DELAY WAS 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956237 ↗
• MalfunctionJan 5, 2026Difficult to Advance

  IT WAS REPORTED ON AN UNKNOWN DATE, THEY TRIED USING THE FIBULINK SYSTEM IN A CASE AND THE FOLLOWING OCCURRED. FIRST TRY THE FIBULINK DID NOT DEPLOY AND THE GOLD AND SILVER TUBES CAME OUT. SECOND AND THIRD TIME - THE SILVER AND GOLD TUBES PULLED OUT WHILE TRYING TO DEPLOY THE SUTURE. SURGICAL DELAY WAS 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956215 ↗
• MalfunctionJan 5, 2026Difficult to Advance

  IT WAS REPORTED ON AN UNKNOWN DATE, THEY TRIED USING THE FIBULINK SYSTEM IN A CASE AND THE FOLLOWING OCCURRED. FIRST TRY THE FIBULINK DID NOT DEPLOY AND THE GOLD AND SILVER TUBES CAME OUT. SECOND AND THIRD TIME - THE SILVER AND GOLD TUBES PULLED OUT WHILE TRYING TO DEPLOY THE SUTURE. SURGICAL DELAY WAS 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956211 ↗
• InjuryNov 6, 2025Migration; Migration

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE TREATED WITH FIBULINK (FGS-1000). TIME FRAME FOR THE SAMPLE WAS BETWEEN FEBRUARY 25, 2021 TO DECEMBER 19, 2024 AT (B)(6) HOSPITALS. SUBJECT ID: (B)(6): 84-YEAR-OLD FEMALE - FIBULINK MIGRATED REQUIRING HARDWARE REMOVAL. IMPLANT(S) INVOLVED: FGS-1000.

  Patient problems: Insufficient Information

  MAUDE report 23489275 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE TREATED WITH FIBULINK (FGS-1000). TIME FRAME FOR THE SAMPLE WAS BETWEEN FEBRUARY 25, 2021 TO DECEMBER 19, 2024. SUBJECT ID: (B)(6): 38-YEAR-OLD FEMALE - PATIENT EXPERIENCED PAIN REQUIRING HARDWARE REMOVAL. IMPLANT(S) INVOLVED: FGS-1000, 1 UNKNOWN PLATE, 4 UNKNOWN SCREWS.

  Patient problems: Pain

  MAUDE report 23487632 ↗
• InjuryNov 6, 2025Migration; Migration

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE TREATED WITH FIBULINK (FGS-1000). TIME FRAME FOR THE SAMPLE WAS BETWEEN (B)(6) 2021 TO (B)(6) 2024. SUBJECT ID 21: 79-YEAR-OLD FEMALE - FIBULINK MIGRATION REQUIRING HARDWARE REMOVAL. IMPLANT(S) INVOLVED: FGS-1000.

  Patient problems: Insufficient Information

  MAUDE report 23487458 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 50 PATIENTS THAT WERE TREATED WITH FIBULINK (FGS-1000). TIME FRAME FOR THE SAMPLE WAS BETWEEN (B)(6) 2021 TO (B)(6) 2024 AT (B)(6) HOSPITALS. SUBJECT ID 16: 38-YEAR-OLD FEMALE - PATIENT EXPERIENCED PAIN REQUIRING HARDWARE REMOVAL. IMPLANT(S) INVOLVED: FGS-1000. 1 UNKNOWN PLATE. 5 UNKNOWN SCREWS.

  Patient problems: Pain

  MAUDE report 23487200 ↗
• MalfunctionNov 6, 2025Failure to Cut; Difficult to Advance; Failure to Cut; Difficult to Advance

  IT WAS REPORTED THAT THE TIBIA SCREW OF FIBULINK PULLED OUT WHEN TENSION CAP WAS PULLING THE FIBULA LINK. THE 4MM STEP DRILL BIT DID NOT DRILL INTO TIBIA SIDE. THE FIBULINK WAS DISCARDED AND ANOTHER PRODUCT WAS USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485473 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE FIBULINK SYNDESMOSIS REPAIR DEVICE FAILED. THE SURGEON REPORTED NOT HEARING THE CLICK FROM THE TORQUE PREVENTION DEVICE. THE SUTURE BROKE AND HAD TO USE THE REMOVAL KIT TO REMOVE THE 3MM SCREW FROM THE TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479138 ↗
• MalfunctionSep 19, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE TIBIA SCREW OF 2 FIBULINKS PULLED OUT OF THE BONE TENSIONING. BOTH OF THE FIBULINK CONSTRUCTS HAD TO BE REMOVED AND DISCARDED. SURGERY WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100919 ↗
• MalfunctionSep 19, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE TIBIA SCREW OF 2 FIBULINKS PULLED OUT OF THE BONE TENSIONING. BOTH OF THE FIBULINK CONSTRUCTS HAD TO BE REMOVED AND DISCARDED. SURGERY WAS DELAYED BY 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100901 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE FIBULINK BROKEN INTRAOP. THERE WAS ORIF FIBULA. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22541278 ↗
• MalfunctionJul 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FGS-1000 FIBULINK, IT WAS REPORTED BY THE SALES CONSULTED THAT WAS IN THE SURGICAL CASE THAT THE FIBULINK PORTION OF FGS-1000 DID NOT ENGAGE WITH THE TIBIA IMPLANT COMPONENT OF THE FIBULINK SYSTEM. THEY ARE NOT SURE AS TO THE REASON THEY DID NOT ENGAGE. A FIBULINK REMOVAL DEVICE WAS USED TO TAKE THE TIBIA COMPONENT OUT AND A NEW FIBULINK FGS-1000 WAS USED WITHOUT INCIDENT. THERE WAS SURGICAL DELAY OF 15 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378722 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE PART BROKE DURING THE CASE. SURGEON USED A SYNDESMOTIC SCREW IN PLACE OF THE DEVICE. THE PROCEDURE AND PATIENT OUTCOME IS REPORTED AS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331957 ↗
• InjurySep 11, 2024Break; Break

  ADDITIONAL EVENT INFORMATION STATES THAT REVISION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 20197304 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE FIBULINK WAS DEFECTIVE. SUTURE BRIDGE BROKE ALMOST IMMEDIATELY AFTER TENSIONING PROCESS BEGAN. ALL STEPS OF THE SURGICAL TECHNIQUE GUIDE WERE FOLLOWED. THERE WAS NO SURGICAL DELAY. THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633107 ↗
• InjuryMar 26, 2024Break; Material Integrity Problem; Migration; Break; Material Integrity Problem; Migration

  THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18980756 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS FURTHER REPORTED THAT TEN (10) MINUTES OF SURGICAL DELAY WAS DUE TO ATTEMPT TO REMOVE THE BROKEN FIBULINKS AND SURGEON ALSO OPTED FOR PUTTING IN 3.5MM CORTEX SCREWS FOR SYNDESMOTIC FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943051 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS FURTHER REPORTED THAT TEN (10) MINUTES OF SURGICAL DELAY WAS DUE TO ATTEMPT TO REMOVE THE BROKEN FIBULINKS AND SURGEON ALSO OPTED FOR PUTTING IN 3.5MM CORTEX SCREWS FOR SYNDESMOTIC FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943048 ↗
• MalfunctionSep 29, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED TO THE SALES REP THAT HE HAD A FIBULINK DRILL BIT BREAK IN SURGERY ON WEDNESDAY MORNING, SEPTEMBER 13, 2023. AS PER THE SURGEON, THE DRILL BIT BROKE AT THE SHOULDER/STEP ON THE DRILL BIT. HE APPARENTLY REMOVED THE BROKEN PIECE AND GAVE IT TO ANOTHER SALES REP. AFTER THE K WIRE WAS INSERTED, THE SURGEON BEGAN USING A STEP DRILL THROUGH THE VA DISTAL FIBULA PLATE, WHICH THEN BROKE IN SYNDESMOSIS. IN ORDER TO REMOVE THE BROKEN DRILL, THE SURGEON PUSHED THE K WIRE THROUGH MEDIALLY AND USED A CANNULATED DRILL BIT. THERE WAS NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) UNK - DRILL BITS: TRAUMA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848171 ↗
• MalfunctionSep 21, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6), 2023 DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) ANKLE PROCEDURE, THE SURGEON IMPLANTED A FIBULINK TO TREAT ANKLE FRACTURE. AS HE TURNED THE BLACK KNOB TO ENGAGE THE FIBULINK AND TIGHTEN THE DEVICE, IT WAS NOTICED THAT THE TORQUE LIMITER WAS NEVER ENGAGED. THE BLACK KNOB REMAINED ABLE TO TURN EVEN AFTER THE LINK WAS FULLY DEPLOYED AND CONFIRMED UNDER X-RAY. THE SURGEON FELT THE SYNDESMOSIS WAS NOT STABLE AND WANTED TO REMOVE THE FIBULINK AND PLACE A SYNDESMOSIS SCREW. HE PULLED THE GOLD AND SILVER WIRES FROM THE INSERTER AND THE LINK AND BUTTON CAME OUT. THE SALES REP LEFT THE ROOM TO GET A REMOVAL KIT TO REMOVE THE TIBIAL SCREW AND AFTER HE RETURNED, A 3.5MM CORTEX SCREW HAD ALREADY BEEN PLACED TO STABILIZE THE SYNDESMOSIS. THE SURGEON DECIDED NOT TO REMOVE THE FIBULINK SCREW FROM THE TIBIA. THE CASE WAS THEN COMPLETED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED. NO ATTEMPT WAS MADE TO REMOVE THE SCREW. THIS REPORT IS FOR ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17789294 ↗