BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBULINK SYNDESMOSIS REPAIR KIT/TI

    MDR report key: 12198223 · Received July 20, 2021

    Report

    Report Number
    3013401747-2021-00049
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 21, 2021
    Report Date
    June 21, 2021
    Manufacturer
    AKROS MEDICAL, INC
    Product Code
    HTN
    UDI-DI
    00863176000317
    PMA / PMN Number
    K173550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: PART: FGS-1100. SYNTHES LOT: 21E004. SUPPLIER LOT: 21E004. RELEASE TO WAREHOUSE DATE: FEBRUARY 11, 2021. EXPIRATION DATE: JANUARY 01, 2024. SUPPLIER: ROBLING MEDICAL, INC. NO NONCONFORMANCE REPORTS (NCRS) WERE 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. VISUAL INSPECTION: FIBULINK® SYNDESMOSIS REPAIR KIT/TI WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE PRIMER CORD SUTURE WAS OBSERVED TO BE BROKEN FROM THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED ON THE RETURNED DEVICE. DIMENSIONAL INSPECTION: COMPLAINT RELEVANT DIMENSIONAL INSPECTION CANNOT BE PERFORMED DUE TO THE POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: -FIBULINK SYNDESMOSIS REPAIR KIT, TI (CURRENT AND MANUFACTURED) NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION THE COMPLAINT COULD BE CONFIRMED FOR THE RETURNED DEVICE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. PER THE SURGICAL TECHNIQUE, TENSION ADJUSTMENT STATES THAT, "ADVANCE THE TENSIONING CAP CLOCKWISE UNTIL IT IS ¿FINGER TIGHT¿ AND THE DESIRED LEVEL OF CORRECTION IS ACHIEVED, WHICH MUST BE CONFIRMED BY FLUOROSCOPY. TURN THE TENSIONING KNOB COUNTERCLOCKWISE TO DECREASE TENSION OF THE FIBULINK IMPLANT AS NEEDED." BUT PER THE COMPLAINT DESCRIPTION, THE TENSIONING CAP WAS TURNED CLOCKWISE TO RELEASE THE TENSION. THE CLOCKWISE MOTION OF THE TENSIONING CAP COULD HAVE CAUSED THE UNINTENDED TENSION IN THE PRIMARY CORD SUTURE WHICH COULD HAVE LED TO THE BREAKAGE OF THE SUTURE. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED ON THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS 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 · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093018 FIBULINK SYNDESMOSIS REPAIR KIT/TI WASHER, BOLT NUT HTN AKROS MEDICAL, INC FGS-1100 21E004 00863176000317

    Patients

    Seq Age Sex Outcome Treatment
    1