BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8 MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 4355734 · Received December 18, 2014

    Report

    Report Number
    3006524618-2014-00349
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 19, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE USING A 1.8 MM Q-FIX ALL SUTURE ANCHOR, THE SUTURE BROKE UPON TORQUING. THIS IMPLANT WAS ABANDONED IN THE BONE, MAKING IT NECESSARY TO DRILL A NEW BONE HOLE TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834630 1.8 MM Q-FIX ALL SUTURE ANCHOR ORTHOPEDIC INTERNAL FIXATION SYSTEMS MBI ARTHROCARE CORPORATION 1080268

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other