BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE

    MDR report key: 2020248 · Received March 10, 2011

    Report

    Report Number
    2032380-2011-00024
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    January 27, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ARTHROCARE CORP
    Product Code
    MBI
    PMA / PMN Number
    K042914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S AGE AND GENDER WAS REQUESTED, BUT TO DATE INFO HAS NOT BEEN PROVIDED. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION, AS IT WAS DISPOSED OF BY THE HOSPITAL. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE LOT HISTORY REVIEW IS COMPLETED. TWO ADDITIONAL DEVICES WERE USED IN THE SAME PROCEDURE AND WERE FILED UNDER MDR 2032380-2011-00025, AND 2032380-2010-00026. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CLINICAL INCIDENT WAS REPORTED TO ARTHROCARE INVOLVING THREE OPUS MAGNUM2 IMPLANTS. ALLEGEDLY ON ALL DEVICES, THE SNARE BROKE AS THE SUTURE WAS BEING REELED INTO THE IMPLANT. ON (B)(6) 2011, IT WAS REPORTED THAT THE CUSTOMER UNDERWENT A PROCEDURE TO REATTACH THE PECTORALIS MAJOR TO THE HUMERAL HEAD. DUE TO THE SNARE BREAKAGE, THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 25 TO 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE REACTIONS TO THE PT AND NO PT INJURY. ADDITIONALLY, ON (B)(6) 2011, IT WAS REPORTED THAT PROCEDURE TOOK PLACE ON (B)(6) 2011. PROCEDURE WAS ORIGINALLY A FULL OPEN PROCEDURE AND NO ADDITIONAL INCISIONS WERE REQUIRED AS A RESULT OF THE ALLEGED SNARE BREAKAGE. THE PT WAS REPORTED AS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS MAGNUM2 IMPLANT KNOTLESS FIXATION DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT MBI ARTHROCARE CORP 1003533

    Patients

    Seq Age Sex Outcome Treatment
    1 Other