BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERTAPE CERCLAGE TENSIONER, REUSABLE

    MDR report key: 24897102 · Received April 16, 2026

    Report

    Report Number
    1220246-2026-02262
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867273986
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNPACKAGED AR-7800, FIBERTAPE® CERCLAGE TENSIONER, BATCH 052144 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION IDENTIFIED SURFACE DAMAGE ALONG THE DISTAL END AND ALONG THE BODY OF THE DEVICE. FUNCTIONAL TESTING REVEALED THAT THE DEVICE FRAYED THE SUTURES WHEN TIGHTENING. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR-AND-TEAR DAMAGE SUSTAINED IN THE FIELD OVER TIME. THE MANUFACTURING DATE IS 2022. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 18-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A QTY. 2 OF AR-7800 FIBERTAPE CERCLAGE TENSIONERS HAD A BURR INSIDE CAUSING THE SUTURES TO TEAR. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 07-APR-2026: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING A TSA TOTAL SHOULDER PROCEDURE WITH A 30-MINUTE CASE DELAY EXPERIENCED. THE CASE WAS COMPLETED WITH SWIVELOCK ANCHORS AND IT UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533407 FIBERTAPE CERCLAGE TENSIONER, REUSABLE MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. FIBERTAPE CERCLAGE TENSIONER, REUSABLE 052144 00888867273986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown