BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIX P KNOTLESS FIXATION SYSTEM

    MDR report key: 2844272 · Received November 8, 2012

    Report

    Report Number
    3006524618-2012-00874
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K120096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE IMPLANTS FAILED TO DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, USING ARTHREX IMPLANTS. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIX P KNOTLESS FIXATION SYSTEM FASTENER, FIXATION, NONDEGRADEABLE, SOFT MBI ARTHROCARE CORPORATION W120050

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other