FIBULINKRecalls & reported problems across all models
Synthes GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 3 models of FIBULINK by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2020 and Sep 17, 2026 — classified as 48 injuries, 100 malfunctions.
The most frequently reported specific device problem is “Break” (69 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FIBULINK problems
Device problems
- Break69
- Device-Device Incompatibility35
- Difficult to Advance18
- Adverse Event Without Identified Device or Use Problem15
- Entrapment of Device10
- Migration9
- Detachment of Device or Device Component2
- Device Slipped2
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- Insufficient Information11
- Foreign Body In Patient9
- No Consequences Or Impact To Patient9
- Pain9
- Failure of Implant5
- No Code Available4
FIBULINK models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FIBULINK FGS-1000Washer, Bolt Nut117 reports
- FIBULINK FGS-1100Washer, Bolt Nut25 reports
- FIBULINK FGS-1300Extractor6 reports
Recent FIBULINK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810277 ↗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 ↗MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ANKLE ORIF SURGERY FOR TRIMALLEOLAR FRACTURE ON TIBIOFIBULAR JOINT. IN THE SURGERY, AFTER THE DFP WAS PLACED, WHILE APPLYING COMPRESSION BETWEEN THE TIBIA AND FIBULA USING FIBULINK, THERE WAS A LOUD CRACKING SOUND AND THE FIBULINK AND TENSIONING CAP CAME OFF TOGETHER. IT APPEARS THAT THE ANCHOR (PERMACORD) HAD BROKEN. SINCE ONLY ONE SET OF FIBULINK WAS AVAILABLE, THE OPERATION WAS TERMINATED BY REMOVING THE TIBIA SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491047 ↗MalfunctionMay 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN INITIAL SURGERY FOR FRACTURE ON ANKLE JOINT WITH FIBULAR LCP DISTAL FIBULA PLATE, POSTERIOR MALLEOLUS 4.0 CCS, AND TIBIOFIBULAR INTERFIBULAR FIBULINK. AFTER THE SURGERY, BONE FUSION WAS CONFIRMED AND AS THE PATIENT REQUESTED REMOVAL, ON (B)(6) 2026, THE REMOVAL SURGERY WAS PERFORMED. DURING THE REMOVAL, THE FOLLOWING EVENTS OCCURRED. A FIBULINK REMOVAL KIT WAS USED. THE CAP WAS REMOVED WITHOUT ISSUE, AND THE FIBULINK WAS REMOVED ALONG WITH IT. THE SURGEON THEN PROCEEDED WITH THE TIBIA SCREW REMOVAL PROCEDURE. A SPECIALIZED SCREWDRIVER WAS INSERTED AND ROTATED, INITIALLY WITH SOME RESISTANCE, BUT AFTER A FEW ROTATIONS, IT SPUN FREELY WITHOUT RESISTANCE. SINCE IT CONTINUED TO SPIN FREELY WITHOUT RESISTANCE, THE EXTRACTION SCREW DESCRIBED IN THE PROCEDURE MANUAL WAS USED. IT WAS INSERTED ALL THE WAY IN, BUT WITH LITTLE RESISTANCE. FLUOROSCOPY REVEALED THAT THE EXTRACTION SCREW HAD ADVANCED TO ABOUT THE MIDDLE OF THE TIBIA SCREW, WHICH WAS DEEMED UNUSUAL. UPON REMOVING THE EXTRACTION SCREW, IT WAS CONFIRMED THAT THE HOLLOW SECTION IN FRONT OF THE TIBIA SCREW WAS SIGNIFICANTLY WIDENED. JUDGING THAT REMOVAL WOULD BE DIFFICULT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152538 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT THE FIBULINK SYNDESMOSIS REPAIR KIT TI WAS USED DURING AN OSTEOSYNTHESIS AND LIGAMENT RECONSTRUCTION PROCEDURE FOR SUPINATION-EXTERNAL ROTATION STAGE 4 ON THE ANKLE JOINT. DURING THE PROCEDURE, AFTER THE DEVICE WAS INSERTED AND COMPRESSION WAS APPLIED WITH THE TENSIONING CAP, THE FIXATION WAS OBSERVED TO BE LOOSE. DESPITE CAREFUL HANDLING, THE SUTURE BROKE, NECESSITATING REMOVAL OF THE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY, AND THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839821 ↗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 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF SURGERY FOR RIGHT ANKLE FRACTURE WITH THE PRODUCT IN QUESTION. IN THE SURGERY, FIBULINK WAS USED FOR INTERTIBIAL FIXATION. AFTER THE TENSIONING CAP WAS PLACED, IT WAS DETERMINED THAT THE CONNECTION WITH THE FIBULINK WAS WEAK, AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE TENSIONING CAP, THE PARMACORD WAS SEVERED, SO IT WAS ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744039 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THE PATIENT UNDERWENT AN ORIF PROCEDURE FOR FIBULAR SHAFT FRACTURE OF THE ANKLE JOINT ON (B)(6) 2026. A FIBULINK WAS USED FOR TIBIOFIBULAR FIXATION. AT THE FINAL STAGE, PERHAPS DUE TO EXCESSIVE PRESSURE, A POPPING SOUND WAS HEARD, AND THE CAP AND FIBULINK CAME OUT. UPON INSPECTION, THE THREAD WAS FOUND TO HAVE BROKEN. THE REMAINING TIBIAL SCREW IN QUESTION WAS REMOVED (NO FRAGMENT REMAINED), AND THE TIBIOFIBULAR JOINT WAS FIXED USING A NON-DEPUY SYNTHES DEVICE. AFTER CONFIRMING THE STABILITY OF THE ANKLE, THE WOUND WAS CLOSED AND THE OPERATION WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A FORTY (40) MINUTE SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546543 ↗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 ↗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 ↗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 23851997 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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