BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAGNUM KNOTLESS IMPLANT

    MDR report key: 3193156 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00240
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K042584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STABILIZATION PROCEDURE USING THE MINIMAGNUM KNOTLESS IMPLANT, THE TENSIONING MECHANISM BROKEN AND THE SUTURE COULD NOT BE TIGHTENED. DUE TO THIS EVENT, THE IMPLANT WAS UNUSABLE AND IT WAS NECESSARY FOR THE SURGEON TO DRILL A NEW BONE HOLE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288181 MINIMAGNUM KNOTLESS IMPLANT FIXATION, ANCHOR, LIGAMENT, NON-BIODEGRADABLE HWC ARTHROCARE CORPORATION 1017925

    Patients

    Seq Age Sex Outcome Treatment
    1 Other