BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS

    MDR report key: 21490044 · Received February 28, 2025

    Report

    Report Number
    1220246-2025-00743
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBI
    PMA / PMN Number
    K172612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS NOT CONFIRMED, AS THE DEVICE(S) WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR EXCESSIVE IMPACTION FORCES., WHICH RESULTED IN THE DEVICE BREAKING. DIRECTIONS FOR USE (DFU) DFU-0054 BIO-FASTAK, FASTAK, SUTURETAK AND FIBERTAK SUTURE ANCHORS G. PRECAUTIONS. 5. INSERT THE ANCHOR WITH THE SAME ORIENTATION AS THAT OF THE PREPARED DRILLED BONE HOLE TO AVOID DAMAGE TO THE ANCHOR. 6. SUTURETAK AND FIBERTAK SUTURE ANCHORS ONLY: ANCHORS LOADED ON FLEXIBLE DRIVERS: THE DRILL GUIDE TIP MUST REMAIN IN CONTACT WITH THE BONE SURFACE DURING THE DRILLING AND IMPLANT IMPACTION STEPS OF THE PROCEDURE. FAILURE TO DO SO MAY RESULT IN DIFFICULTY SEATING THE IMPLANT TO ITS INTENDED DEPTH. AVOID EXCESSIVE IMPACTION DURING ANCHOR INSERTION AS THIS COULD LEAD TO INSERTER DAMAGE AND/OR BREAKAGE. IF INSERTION RESISTANCE IS ENCOUNTERED, DO NOT IMPACT HARDER. REPLACE THE IMPLANT AND REPEAT THE DRILLING/INSERTION PROCESS.

    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 20TH FEBRUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE THAT FOR AN AR-8990, FIBERTAK¿ DX SUTURE ANCHOR, #1 FW W/NEEDLES, VE5, THE TIP OF THE IMPLANT BROKE. THIS WAS DETECTED DURING USE IN A PERONEAL TENDON SUBLUXATION REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE PERONEAL TENDON WAS STITCHED AND ANCHORED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030456 DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS NON-DEGRADABLE FIXATN FASTENER MBI ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS 15013382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown