BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL

    MDR report key: 24430518 · Received February 24, 2026

    Report

    Report Number
    1220246-2026-00895
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 30, 2026
    Report Date
    May 21, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    UDI-DI
    00888867377295
    PMA / PMN Number
    K200341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE AR-8991 FIBERTAK DX SUTURE ANCHORS DID NOT MAINTAIN TENSION THROUGHOUT THE RANGE OF MOTION. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2026: THIS OCCURRED DURING A LATERAL EPICONDYLITIS (TENNIS ELBOW) PROCEDURE. AFTER EXPERIENCING THREE MALFUNCTIONS, THEY CONVERTED TO A DIFFERENT KNOTTED ANCHOR AND SUCCESSFULLY COMPLETED THE CASE USING AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR, DOUBLE-LOADED. THE PROCEDURE WAS DELAYED BY APPROXIMATELY TEN MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517063 DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #2 MTS W/ NDL 15428166 00888867377295

    Patients

    Seq Age Sex Outcome Treatment
    1