BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8 MM Q-FIX ALL SUTURE ANCHOR

    MDR report key: 4426408 · Received January 15, 2015

    Report

    Report Number
    3006524618-2015-00004
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 26, 2014
    Report Date
    December 26, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K133727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A 1.8MM Q-FIX ALL SUTURE ANCHOR, THE INITIAL ANCHOR PREMATURELY DEPLOYED AND HAD TO BE REMOVED. A SECOND 1.8MM Q-FIX ALL SUTURE ANCHOR WAS INSERTED, HOWEVER, FAILED TO DEPLOY, GETTING STUCK IN THE INSERTION SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35463 1.8 MM Q-FIX ALL SUTURE ANCHOR ORTHOPEDIC INTERNAL FIXATION SYSTEMS MBI ARTHROCARE CORPORATION 1082817

    Patients

    Seq Age Sex Outcome Treatment
    1 Other