FIBULINK FGS-1300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00863176000324), received between Nov 2, 2020 and Dec 19, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF FIBULINK IMPLANTS THAT HAD BEEN USED TO TREAT DISTAL FIBULA FRACTURES. WHEN THE CAP WAS REMOVED, THE FIBULA LINK DID NOT COME OUT WITH THE CAP, SO THE SURGEON ATTEMPTED TO REMOVE THE TIBIA SCREW WITH THE DEVICE WITH A BLACK HANDLE AS PER THE SURGICAL TECHNIQUE GUIDE BUT COULD NOT REMOVE THE SCREW. A NEW INCISION WAS MADE ON THE MEDIAL SIDE OF THE TIBIA, A WOUND WAS CREATED WITH A 3.5 MM DRILL, AND THE TIBIAL SCREW WAS REMOVED USING A 3.5 MM HOLLOW REAMER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23852006 ↗
• MalfunctionAug 14, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT REMOVAL SURGERY FOR THE FIBUKINK DUE TO BONE UNION. THE PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2024. THE SURGEON WAS FOLLOWING THE PROCEDURE AS USUAL, BUT THE TIBIAL SCREWDRIVER GOT STUCK AND WHEN IT WAS REMOVED THE HEIGHT OF THE TIBIA AND FIBULA HAD CHANGED. THEREFORE, THE SURGEON TRIED TO REMOVE THE FIBUKINK BY ADJUSTING THE HEIGHT OF THE TIBIA AND FIBULA, BUT THERE WERE SEVERAL TIMES WHEN THE TIBIAL SCREWDRIVER GOT CAUGHT ON THE STEP AND ONLY THE TIBIAL SCREWDRIVER CAME OUT. WHEN RECONNECTING, IT TURNED A LITTLE MORE VIGOROUS AND THERE WAS NO LONGER ANY CATCH. THE THREADS ON EITHER THE FIBUKINK OR THE TIBIAL SCREWDRIVER HAD BECOME STRIPPED, MAKING IT DIFFICULT TO REMOVE, SO THE SURGEON DECIDED TO DRIVE THE FIBUKINK IN AND LEAVE IT IN THE BODY. THE SURGEON STATED THAT HE WOULD LIKE TO CONFIRM WHETHER THIS CASE WAS CAUSED BY STRIPPED SCREW THREADS ON THE DRIVER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809209 ↗
• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, SURGEON HAD THE TIBIA SCREW IN, TENSIONING CAP ON, AND A HEMOSTAT ON THE SILVER TUBE. SURGEON WENT TO TENSION THE SUTURE CORD AND THE SUTURE CORD BROKE, PULLING OUT THE ENTIRE SUTURE CORD. SURGEON THEN HAD TO OPEN A REMOVAL KIT TO GET THE TIBIA SCREW OUT AND THE TIBIAL REMOVAL SCREWDRIVER WOULD NOT RECESS IN. THE TIBIA SCREW WAS LEFT IN THE PATIENT. THERE WAS SURGICAL DELAY OF FIFTEEN MINUTES PUT THE FIBULINK IN AND ANOTHER FIFTEEN TRYING TO GET IT OUT; TOTAL OF 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564809 ↗
• InjuryAug 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON PERFORMED AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF BILMALLEOLAR ANKLE FRACTURE WITH SYNDESMOTIC INJURY. AFTER USING A SYNTHES VA LCP DISTAL FIBULA PLATE TO REPAIR FIBULA FRACTURE, AND TWO CANNULATED SCREWS TO REPAIR THE MEDIAL MALLEOLUS. SURGEON THEN USED A LARGE TENACULUM TO REDUCE THE SYNDESMOSIS INJURY AND BEGAN PREPARING THE BONE FOR THE FIBULINK FOLLOWING THE SURGICAL TECHNIQUE. ONCE THE SURGEON INSERTED THE TIBIA SCREW TO THE CORRECT DEPTH THE INDICATOR GROOVE WAS VISIBLE JUST LATERAL TO THE PLATE AND A STANDARD TENSIONING CAP WAS USED. THE SURGEON SECURED A CLAMP TO THE SILVER TUBE AND PULLED LATERALLY AND ENGAGED THE TENSIONING CAP WITH THE LINK BY TURNING THE CLAMP CLOCKWISE. THE CAP DID ENGAGE THE FIBULINK BUT WOULD NOT TIGHT TO THE DEGREE THAT IT MAINTAINED REDUCTION OF THE SYNDESMOSIS INJURY. AFTER ATTEMPTING TO TIGHTEN THE TENSIONING CAP FOR SEVERAL MINUTES, WHILE ENSURING LATERAL TENSION ON SILVER TUBE TO PREVENT ROTATION I SUGGESTED THAT THE SURGEON PULL BACK SLIGHTLY ON THE TENSIONING KNOB. ONCE THE SURGEON PULLED BACK ON TENSIONING KNOB IT DISENGAGED FROM THE TENSIONING CAP. UNSUCCESSFUL ATTEMPTS WERE MADE TO RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388091 ↗
• MalfunctionJun 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE FIBULINK SCREW WAS INSERTED INTO THE TIBIA AND THEN ONCE THE SILVER TUBE WAS FILLED THE OTHER WAY THE LINK DID NOT ENGAGE INTO THE CAP MOST LIKELY THE EXTENDED CAP WAS NEEDED. SURGEON PULLED ON THE SILVER TUBE AGAIN TO TRY TO ENGAGE IT AND THE TUBE RELEASED. THEREFORE, RELEASING THE ENTIRE IMPLANT BEFORE THE PROCEDURE WAS ABLE TO BE COMPLETED AND THEN THE SCREWDRIVER WOULD NOT ENGAGE INTO THE SCREW TO BE ABLE TO REMOVE IT, SO A REMOVAL KIT HAD TO BE OPEN AND USED TO REMOVED THE IMPLANT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWENTY(20) MINUTES DELAY. THIS REPORT IS FOR ONE (1) FIBULINK® REMOVAL KIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028939 ↗
• MalfunctionNov 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ANKLE ON (B)(6) 2020, THE FIBULINK SYNDESMOSIS REPAIR KIT AND FIBULINK REMOVAL KIT DID NOT ENGAGE INTERNAL THREADS. THE PROCEDURE WAS COMPLETED BY USING A REGULAR 3.5 CORTEX SCREW. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10770770 ↗