BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAGNUM KNOTLESS IMPLANT

    MDR report key: 638255 · Received September 23, 2005

    Report

    Report Number
    2032380-2005-00006
    Event Type
    Other
    Date Received
    September 23, 2005
    Date of Event
    September 17, 2004
    Report Date
    September 21, 2005
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HTY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 05/2005, ARTHROCARE WAS NOTIFIED OF A CLINICAL INCIDENT INVOLVING A MAGNUM KNOTHLESS IMPLANT. THE PT HAD A SHOULDER ARTHROSCOPY FOR BILATERAL ROTATOR CUFF INJURIES IN 09/2004. IN MARCH OF 2005 THE PT COMPLAINED OF CONTINUED PAIN SO THE SURGEON X-RAYED THE SHOULDER AND NOTICED A SMALL WIRE EXTENDING FROM THE ANCHOR INTO TISSUE. SURGEON FELT IT IN THE PT'S BEST INTEREST TO PERFORM AN EXPLORATORY ARTHROSCOPIC SURGERY IN 05/2005. DURING THE SECOND SURGERY, IT WAS FOUND THAT THERE WAS A SMALL WIRE EXTENDING FROM THE ANCHOR. IT WAS ENCASED IN CALCIUM AND CONFIRMED THROUGH FLOROSCOPY. THE ROTATOR CUFF REPAIR LOOKED GOOD. THE SURGEON DETERMINED THAT A REPEAT ROTATOR CUFF REPAIR AND REMOVAL OF THE ANCHOR WAS NOT WARRANTED SINCE THE WIRE WAS ENCAPSULATED AND THE ORGINAL REPAIR WAS GOOD. THE PT HAS BEEN SEEN IN FOLLOW-UP EVALUATIONS AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNUM KNOTLESS IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE HTY ARTHROCARE CORP. NA W040277

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention