BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK® SYNDESMOSIS REPAIR KIT/SS

    MDR report key: 13684739 · Received March 7, 2022

    Report

    Report Number
    1719045-2022-00006
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    January 12, 2022
    Report Date
    March 4, 2022
    Manufacturer
    MONUMENT DEPUY SYNTHES PRODUCTS INC
    Product Code
    HTN
    UDI-DI
    00863176000300
    PMA / PMN Number
    K162805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PART #: FGS-1000, SYNTHES LOT #: 21E032, SUPPLIER LOT #: 21E032, RELEASE TO WAREHOUSE DATE: 07 JAN 2022, EXPIRATION DATE: 11 JAN 2024, SUPPLIER: ROBLING MEDICAL, INC., NO NCR'S GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. THIS REPORT WAS INITIALLY SUBMITTED ON TIME ON FEBRUARY 11, 2022. ADVISED BY FDA ON MARCH 3, 2022 TO RESUBMIT THIS MEDWATCH REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION(ORIF) OF ANKLE PROCEDURE WITH FIBULINK. THE GUIDE PIN WAS INSERTED, AND THE PILOT HOLE WAS DRILLED UTILIZING THE STEPPED DRILL PROVIDED IN THE SET. THE TIBIA SCREW WAS INSERTED TO THE APPROPRIATE DEPTH AND WAS DETERMINED THE STANDARD TENSIONING CAP WAS APPROPRIATE. THE TENSIONING NOB WAS INSERTED AND THE SILVER TUBE WAS DEPLOYED TO ENGAGE THE FIBULA LINK. THE TENSIONING NOB WAS THEN UTILIZED TO TENSION THE LINK AND SUTURE BRIDGE. DURING TENSIONING AN AUDIBLE SNAP OCCURRED AND THE TENSION NOB AS WELL AS THE SILVER AND GOLD DISENGAGED FROM THE FIBULA TENSIONING CAP. AT THIS TIME A REMOVAL KIT WAS OPENED TO REMOVE THE TIBIAL SCREW AND FIBULA LINK AS THEY WERE STILL IMPLANTED IN THE PATIENT. DUE TO THE LINK BEING STILL ATTACHED REMOVAL OF THE TIBIAL SCREW WAS PERFORMED IN A TIMELY FASHION. A SECOND FIBULINK WAS THEN OPENED, AND THE TIBIAL SCREW INSERTED INTO THE PREVIOUS HOLE. IT WAS INSERTED SLIGHTLY MORE MEDIAL TO ENGAGE FIXATION. AT THIS TIME IT WAS DETERMINED THAT THE LONG TENSIONING CAP WOULD BE MORE APPROPRIATE. TENSIONING NOB/CAP WAS INSERTED AND ENGAGED. UPON TENSIONING, THE PERMACORD SUTURE BRIDGE BROKE AND PULLED OUT FROM THE TIBIAL SCREW. THE FIBULA TENSION CAP WAS ONCE AGAIN REMOVED AS WELL AS THE FIBULA LINK. THE HEXALOBE REMOVAL INSTRUMENT WAS THEN USED TO TRY AND REMOVE THE TIBIAL SCREW. IT WAS FOUND THAT THE TIBIAL SCREW WOULD ONLY REVERSE TO THE APERTURE OF THE MEDIAL CORTEX OF THE FIBULA. AT THIS POINT THE TIBIAL SCREW HAD NO PURCHASE ON THE GLIDING HOLE AND COULD NOT BE REMOVED. MULTIPLE INSTRUMENTS FROM THE SMALL FRAGMENT AS WELL AS THE SYNTHES SCREW REMOVAL WERE APPLIED TO TRY AND REMOVE THE SCREW. DURING THIS PROCESS IT WAS DETERMINED THAT THE BEST COURSE OF ACTION WAS TO PUSH/SCREW THE TIBIAL SCREW MEDIAL AND REMOVE FROM A SMALL INCISION ON THE MEDIAL PORTION OF THE ANKLE. ALSO TO BE NOTED, AT NO TIME WAS AN AUDIBLE CLICK FROM THE TORQUE LIMITING FEATURE OF THE BLACK TENSIONING CAP WITH EITHER FIBULINK IMPLANT. WITH THE FIBULINK IMPLANTS REMOVED FROM THE PATIENT, THE SURGEON THEN UTILIZED THE SYNTHES SMALL FRAGMENT SET TO COMPLETE THE SYNDESMOSIS. A 5 HOLE 1/3 TUBULAR PLATE WAS CUT TO DOWN TO TWO HOLES. THIS MODIFIED PLATE WAS THEN PLACED LATERAL ON THE FIBULA AND TWO 50MM 3.5 CORTEX SCREWS WERE INSERTED TO COMPLETE THE SYNDESMOSIS. THE EXPECTED CASE TIME WAS LENGTHENED APPROXIMATELY 30 MINUTES DUE TO THE MULTIPLE INSERTIONS AND REMOVALS OF THE FIBULINK IMPLANTS. THE ORIGINAL DRILLED HOLE FOR THE FIBULINK WAS NOT UTILIZED AS THE PLATE AND SCREW CONSTRUCT WERE APPLIED SUPERIOR. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS. THIS REPORT INVOLVES ONE (1) FIBULINK(R) SYNDESMOSIS REPAIR KIT/SS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288428 FIBULINK® SYNDESMOSIS REPAIR KIT/SS WASHER, BOLT NUT HTN MONUMENT DEPUY SYNTHES PRODUCTS INC FGS-1000 21E032 00863176000300

    Patients

    Seq Age Sex Outcome Treatment
    1 Male FIBULINK® REMOVAL KIT| FIBULINK® SYNDESMOSIS REPAIR KIT/SS| UNK - DRILL BIT: TRAUMA| UNK - EXTRACTION INSTRUMENTS| UNK - GUIDES/SLEEVES/AIMING: GUIDE| UNK - INSERTION INSTRUMENT: TRAUMA