BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAPE CERCLAGE TENSIONER, REUSABLE

    MDR report key: 19196730 · Received April 26, 2024

    Report

    Report Number
    1220246-2024-02488
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 10, 2021
    Report Date
    April 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867273986
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT CANNOT BE CONFIRMED. ONE UNPACKAGED AR-7800, BATCH 051650 CERCLAGE TENSIONER WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED SIGNS OF WEAR AND TEAR ACROSS THE DEVICE, SUCH AS DISCOLORATION AND A SECTION OF CHIPPED COATING ALONG THE INNER DIAMETER OF THE C13679-01 LOWER BODY COMPONENT. THE OBSERVED CONDITION OF THE TENSIONER IS CONSISTENT WITH THE MANUFACTURE DATE OF 2017. THE DEVICE WAS FUNCTIONALLY TESTED WITH THE RETURNED AR-7801, BATCH 104731 THAT WAS RETURNED ON (B)(6). NO PROBLEM WAS NOTED. AS THE FIBERTAPE DETAILED IN THE EVENT DESCRIPTION WAS NOT RETURNED, THE REPORTED FAILURE MODE CANNOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DISTAL FEMUR FRACTURE SURGERY THREE FIBERTAPES (AR-7267, LOT S705864) BROKE INSIDE THE PATIENT WHILE USING THE CERCLAGE TENSIONER (AR-7800, LOT 051650). ONE BROKE DURING INITIAL TENSIONING AND THE SECOND AND THIRD BROKE WHEN THE FINAL TENSIONING ON TOP OF THE HALF HITCH WAS DONE. ALL THREE DEVICES BROKE IN THE KNOT. THE BROKEN DEVICE CERCLAGE WAS REMOVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON SWITCHED TO A CERCLAGE WIRE IN METAL. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870765 FIBERTAPE CERCLAGE TENSIONER, REUSABLE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE 051650 00888867273986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown