BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK KNOTLESS IMPLANT

    MDR report key: 2850181 · Received November 21, 2012

    Report

    Report Number
    3006524618-2012-00923
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K090615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE USING SPEEDLOCK KNOTLESS IMPLANT, THE ANCHOR FAILED TO DEPLOY AND THE SUTURE WOULD NOT LOCK. THE SURGEON DRILLED A NEW BONE HOLE AND COMPLETED THE PROCEDURE USING A BACK-UP SPEEDLOCK KNOTLESS IMPLANT. NO DEBRIS FROM THE INITIAL ANCHOR WAS LEFT INSIDE THE PT'S BONE. THERE WAS NO SIGNIFICANT DELAY OR PT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDLOCK KNOTLESS IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT MBI ARTHROCARE CORPORATION 1025933

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other