BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8 MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 4349747 · Received December 12, 2014

    Report

    Report Number
    3006524618-2014-00347
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 17, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE USING A 1.8MM Q-FIX ALL SUTURE ANCHOR, THE SUTURE BROKE UPON TENSIONING. THE ANCHOR WAS ABANDONED IN THE BONE. IT WAS NECESSARY TO DRILL A NEW BONE HOLE AND USE A BACKUP ANCHOR, 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
    808130 1.8 MM Q-FIX ALL SUTURE ANCHOR FIXATION MBI ARTHROCARE CORPORATION 1078420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other