FIBULINK FGS-1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00863176000317), received between Aug 31, 2020 and Sep 17, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionNov 19, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH FIBULINK FOR FIBULA FRACTURES (WEBER-C). WHILE TENSIONING THE FIBULINK IMPLANT, THE TENSION SUDDENLY DISAPPEARED. THE IMPLANT WAS REMOVED, AND IT WAS FOUND THAT THE PERMACORD HAD BROKEN. THE SURGEON WAS HOLDING THE SILVER TUBE WITH PLIERS AND ROTATING THE TENSION CAP CLOCKWISE, BUT IT APPEARS THAT THE GRIP ON THE SILVER TUBE WAS WEAK, CAUSING THE PERMACORD TO TWIST AND BREAK. SINCE THE BONE QUALITY WAS GOOD, THE PROCEDURE WAS COMPLETED WITHOUT FIBULINK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598415 ↗
• MalfunctionSep 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR FRACTURE ON THE ANKLE WITH THE PRODUCTS IN QUESTION. AFTER THE SURGERY ON (B)(6) 2025, THE REMOVAL SURGERY WAS PERFORMED. THE REASON FOR THE REMOVAL IS UNKNOWN. IN THE SURGERY, THE TIBIAL SCREW IN QUESTION WAS SPINNING FREELY, MAKING IT DIFFICULT TO REMOVE. THE PRODUCT WAS REMOVED FROM THE OTHER SIDE BY HAMMERING IT LITTLE BY LITTLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23051148 ↗
• MalfunctionAug 15, 2025Break; Entrapment of Device; Break; Entrapment of Device

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS AN INFECTION THAT WAS CONFIRMED AFTER PRIMARY SURGERY AND REMOVAL SURGERY WAS PERFORMED. THIS PC REPORTS THE SCREW COULD NOT BE REMOVED IN THE REMOVAL SURGERY ON (B)(6) 2025. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY SURGERY FOR OPEN ANKLE FRACTURE-DISLOCATION WITH FIBULINK REPAIR KIT. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE FIBULINK REPAIR KIT WAS SCHEDULED TO BE REMOVED DUE TO SIGNS OF INFECTION IN THE WOUND. ON (B)(6) 2025, THE SURGERY WAS PERFORMED TO REMOVE THE FIBULINK REPAIR KIT ALONG WITH A DISTAL FIBULA PLATE FROM ANOTHER MANUFACTURER. DURING SURGERY, THE SURGEON USED A FIBULINK REMOVAL KIT TO ATTEMPT REMOVAL, BUT THE TIBIAL SCREW WOULD NOT TURN. THEREFORE, THE SURGEON GAVE UP, CONSIDERING THE RISK OF DEFORMATION OF THE TIP OF THE TIBIAL SCREWDRIVER OR THE TIBIAL SCREW HEAD. AFTER REMOVING THE FIBULINK, THE SURGEON USED A TIBIAL SCREW REMOVER ON THE TIBIAL SCREW, BUT THE TIBIAL SCREW STILL DID NOT ROTATE. EVEN WHEN EXTRACTION SCREWS (309.510/309.520) WERE USED, THE TIBIAL SCREW DID NOT ROTATE. UPON CHECKING THE IMAGE, DAMAGE TO THE TIBIAL SCREW HEAD WAS CONFIRMED. THE SURGEON DET

  Patient problems: Foreign Body In Patient

  MAUDE report 22819906 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SCREW COULD NOT BE REMOVED IN THE REMOVAL SURGERY ON (B)(6) 2025. THIS PC REPORTS AN INFECTION THAT WAS CONFIRMED AFTER PRIMARY SURGERY AND REMOVAL SURGERY WAS PERFORMED. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT PRIMARY SURGERY FOR OPEN ANKLE FRACTURE-DISLOCATION WITH FIBULINK REPAIR KIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED BY THE SURGEON THAT THE FIBULINK REPAIR KIT WAS SCHEDULED TO BE REMOVED DUE TO SIGNS OF INFECTION IN THE WOUND. ON (B)(6) 2025, THE SURGERY WAS PERFORMED TO REMOVE THE FIBULINK REPAIR KIT ALONG WITH A DISTAL FIBULA PLATE FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22819905 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ANKLE ORIF SURGERY FOR ANKLE FRACTURES WITH FIBULINK REPAIR KIT. THE SURGEON INSERTED A TIBIAL SCREW ON THE TIBIAL SIDE, REMOVED THE DRIVER AND ATTACHED A TENSIONING CAP, THEN GRASPED THE SILVER GUIDE TUBE WITH A NEEDLE HOLDER AND PULLED IT OUTWARD, BUT THE PERMACORD DID NOT DEPLOY. THE SURGEON TRIED TO PULL ON THE SILVER GUIDE TUBE WITH PLIERS AND BOTH THE SILVER AND GOLD GUIDE TUBES CAME OUT. THE SURGEON AGAIN ATTEMPTED TO INSERT THE SILVER GUIDE TUBE THROUGH THE TENSIONING CAP BUT WAS UNABLE TO DO SO AND AFTER SEVERAL ATTEMPTS THE TIP OF THE SILVER GUIDE TUBE BECAME BENT. THEREFORE, THE FIBULA-LINK AND TENSIONING CAP COULD NOT BE FITTED. IN THE END, SINCE NO REMOVAL INSTRUMENT WAS PREPARED, THE SURGEON REMOVED THE TENSIONING CAP, GAVE UP ON THE FIBULINK WITH THE FIBULA-LINK REMAINING IN THE TIBIAL SCREW ON THE TIBIAL SIDE, AND COMPLETED THE SURGERY BY INSERTING A CORTEX SCREW THROUGH THE DISTAL SCREW HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650196 ↗
• MalfunctionJul 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FIBULAR FRACTURE AND TIBIOFIBULAR FIXATION WITH THE PLATE. AFTER THE TIBIOFIBULAR FIXATION, THE SURGEON UNPACK AND TOOK A LOOK AT THE TIBIA SCREWDRIVER SEEMED THE CONNECTING PART WHERE THE TIBIA SCREW WAS ATTACHED LOOKED A LITTLE BENT, SO THE SURGEON HAD THEM MANUALLY PUSH IT IN AND STRAIGHTEN IT. THE SALES REP ASKED THEM TO INSERT IT AS IT WAS, AND WHEN THE TIBIAL SCREW WAS BURIED IN THE CORRECT POSITION, THE SALES REP ASKED THE SURGEON TO UNTIE THE SUTURE THREAD AND REMOVE THE DRIVER ATTACHMENT. IT CAME OUT EASILY, BUT AT THE SAME TIME, THE SILVER AND GOLD TUBES INSIDE HAD COME OUT. THE SURGEON AND THE SALES REP JUDGED THE PROCEDURE TO BE DIFFICULT AFTER THAT, SO THE SURGEON HAD THEM REMOVE THE TIBIAL SCREW AND TRIED TO ASSEMBLE IT WITH EACH TUBE, BUT IT DIDN'T WORK, SO THE SURGEON USED A DIFFERENT PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. OTHER THAN THE PATIENT'S GOOD BONE QUALITY, THE SURGEON DIDN'T SEEM TO HAVE HANDLED IT PARTICULARLY ROUGHLY, SO IT SEEMED LIKE THERE WAS SOME KIND OF INTERNAL LOOSENING, BUT THE SURGEON SAID THERE WAS A SPARE SO IT WASN'T A PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609541 ↗
• MalfunctionJul 14, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE FIBULINK. THE FIBULINK IN QUESTION, WHICH WAS INSERTED IN (B)(6) 2024, WAS REMOVED, BUT IT BECAME DIFFICULT TO REMOVE THE FIBULA LINK AND TIBIA SCREW, AND AS A RESULT, THE FIBULA LINK AND THE TIBIA SCREW WERE LEFT IN THE PATIENT'S BODY. THE TENSIONING CAP WAS REMOVED, BUT WHEN WE TRIED TO REMOVE THE FIBULA LINK WITH A TIBIA SCREWDRIVER, IT DID NOT ENGAGE, AND ONLY THE FIBULA LINK MOVED TO THE TIBIA SIDE, AND THE TIP OF THE DRIVER HIT THE CORTICAL BONE ON THE OPPOSITE SIDE OF THE FIBULA, CAUSING IT TO SPIN FREELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. SURGEON ¿S COMMENT: THE DIFFICULTY IN REMOVAL WAS DUE TO A PROBLEM WITH THE IMPLANT STRUCTURE, AND THE PRODUCT WAS NOT INTENDED TO BE REMOVED. IT MAY BE POSSIBLE TO REMOVE IT BY DRILLING A LARGER HOLE, BUT THE SURGEON DID NOT WANT TO DESTROY THE BONE UNNECESSARILY, SO THIS TIME IT WAS LEFT IN PLACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22493921 ↗
• MalfunctionJun 19, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE FIBULINK. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE SURGEON CONSULTED THE SALES REP ABOUT REMOVING THE FIBULINK IN QUESTION AND SHOWED THE SALES REP IMAGES TO CONFIRM OTHER IMPLANTS IN USE AND THE SITUATION. THE IMPACTED PRODUCT HAD BEEN USED IN ALL 10 HOLES OF THE METAPHYSEAL PLATE. WHEN THE SALES REP HAD A CLOSE LOOK AT THE IMAGES REVEALED A GAP BETWEEN THE TENSIONING CAP AND THE FIBULINK, AND THAT EACH OTHER WERE NOT CONNECTED. THE REMOVAL SURGERY WAS PLANNED IN (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289272 ↗
• MalfunctionMar 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL TIBIA-FIBULA FRACTURE WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE FIBULA WAS FIRST FIXED WITH THE DISTAL FIBULA, AND THEN A FIBULINK WAS USED BECAUSE THERE WAS SOME LOOSENESS BETWEEN THE TIBIA AND FIBULA. K-WIRE WAS INSERTED SLIGHTLY FORWARD FROM THE DISTAL END OF THE SHAFT OF THE DISTAL FIBULA, AND THEN A STEP DRILL WAS PERFORMED, BUT THE THICK PART OF THE FIBULA SIDE THAT WAS BEING SCRAPED HIT THE PLATE, SO IT TOOK A LOT OF TIME. AFTER THAT, THE SURGEON INSERTED THE TIBIAL SCREW, PULLED THE SILVER GUIDE TUBE WITH A NEEDLE HOLDER, AND APPLIED TENSION WHILE TURNING THE TENSIONING CAP, BUT BECAUSE IT WAS TOO MUCH, HE LOOSENED IT BY TURNING IT IN THE OPPOSITE DIRECTION AND REMOVED THE TENSIONING KNOB, AND THE TENSIONING CAP CAME OFF TOGETHER. THE SILVER GUIDE TUBE WAS REINSERTED, BUT IT WAS DIFFICULT TO INSERT, AND THE TIP OF THE SILVER GUIDE TUBE BENT DURING THE PROCEDURE, MAKING IT IMPOSSIBLE TO INSERT INTO THE FIBRALINK. THE SURGEON ADJUSTED THE SHAPE SEVERAL TIMES BUT WAS UNABLE TO INSERT IT, SO FINALLY HE MADE THE SKIN INCISION A LITTLE LARGER, HELD THE FIBRALINK FROM THE FRONT WITH A FORCE

  Patient problems: Insufficient Information

  MAUDE report 21536816 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WAS STABLE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED AND NO REMOVAL SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691077 ↗
• MalfunctionOct 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ANKLE LIGAMENT RECONSTRUCTION WITH FIBULINK FOR TIBIOFIBULAR LIGAMENT INJURY. DURING SURGERY, THE SILVER TUBE CAME OFF. WHEN THE SURGEON TRIED TO REINSERT, IT BECAME UNCLEAN. A NEW FIBULINK WAS USED FOR THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397856 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE FIBULINK SYNDESMOSIS REPAIR KIT TITANIUM WAS IMPLANTED, AND IT WAS DETERMINED THAT THE LINK WAS PULLED LATERALLY ENOUGH, THE TENSIONING CAP WAS TURNED KIND OF CLOCKWISE TO RELEASE THE TENSION TO IN ORDER TO REVIEW TENSION. DURING THIS PROCESS, THE PRIMER CORD SUTURE BROKE FROM THE LINK AND THE IMPLANT HAVE TO BE EXTRACTED AND A SECOND REPLACEMENT FIBULINK IMPLANT WAS USED. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) FIBULINK® SYNDESMOSIS REPAIR KIT/TI. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198223 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, DURING AN OPEN REDUCTION AND INTERNAL FIXATION(ORIF) ANKLE WITH SYNDESMOSIS REPAIR, WHILE TURNING THE TENSION KNOB ON THE FIBULINK, THE SUTURE BROKE. THEY HAD TO REMOVE THE BROKEN IMPLANT AND IMPLANT A NEW FIBULINK. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN(10) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/TI. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921621 ↗
• MalfunctionFeb 19, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A COUPLE OF FIBULINK THAT BREAK, THE FGS-11, ONE OF THEM WON¿T TIGHTEN OUT. THE OTHER ONE, THE ACTUAL HEAD OF THE CAP WAS BROKE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) FIBULINK SYNDESMOSIS REPAIR KIT/TI THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350585 ↗
• MalfunctionFeb 19, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A COUPLE OF FIBULINK THAT BREAK, THE FGS-11, ONE OF THEM WON¿T TIGHTEN OUT. THE OTHER ONE, THE ACTUAL HEAD OF THE CAP WAS BROKE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) FIBULINK SYNDESMOSIS REPAIR KIT/TI THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350525 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FIBULA AND MEDIAL MALLEOLUS WITH A HOOK PLATE AND SYNDESMOTIC REPAIR WITH THE FIBULINK. THERE WAS DIFFICULTY ENGAGING THE FIBULINK DEVICE INTO THE TIBIA COMPONENT. A LARGER HAT WAS USED AND ENGAGED RIGHT AWAY. POSTOPERATIVELY, THE PATIENT HAD NO PAIN TO THE ANKLE BUT MILD PAIN ALONG THE PERONEAL TENDONS. THE PATIENT WAS DOING WELL, WALKING IN REGULAR SHOES AND BACK TO ALL ACTIVITIES WITH MINIMAL SWELLING. THE WOUND HEALED IN A DURATION OF SIX (6) MONTHS. THIS REPORT IS FOR ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/TI. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11313338 ↗
• InjuryDec 15, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE PATIENT¿S FIBULINK SYNDESMOSIS REPAIR KIT BROKE POST-OP. ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE AS THE SUTURE BRIDGE OF THE FIBULINK SYNDESMOSIS REPAIR KIT HAD BROKEN AND WAS NO LONGER INTACT WITH THE FIBULA LINK. ALSO, THE HEAD OF THE FIBULA TENSIONING CAP HAD SHEARED OFF AND WAS NO LONGER PART OF THE TENSIONING CAP-FIBULA LINK JUNCTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH FIBULINK SYNDESMOSIS REPAIR KIT ON (B)(6) 2020, WITH NO REPORTED INJURY OR FALL AND DID NOT KNOW THE DEVICE FAILED UNTIL CLINICAL FOLLOW-UP. THE IMPLANT WAS REMOVED WITHOUT COMPLICATIONS. THE PATIENT CLAIMS TO HAVE BEEN COMPLIANT AND NON-WEIGHT BEARING. THIS REPORT INVOLVES ONE (1) FIBULINK® SYNDESMOSIS REPAIR KIT/TI. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11006446 ↗
• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT DURING A SYNDESMOSIS REPAIR ON (B)(6) 2020, THE TENSION CAP HEAD OF THE FIBULINK SYNDESMOSIS REPAIR KIT BROKE OFF. THE ISSUE OCCURRED WHEN THE SURGEON WAS INSERTING THE TENSION KNOB WHILE ATTEMPTING TO INSERT THE TIBIA LINK DEVICE THROUGH A TITANIUM PLATE. ANOTHER FIBULINK KIT WAS USED INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: TITANIUM PLATE (PART: 441.371, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A FIBULINK® SYNDESMOSIS REPAIR KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10471795 ↗