BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

    MDR report key: 4202571 · Received September 18, 2014

    Report

    Report Number
    3006524618-2014-00288
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ARTHROCARE CORP
    Product Code
    MBI
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE, THE ANCHOR DID NOT DETACH FROM THE INSERTER HANDLE. THE ENTIRE IMPLANT HAD TO BE PULLED OUT OF THE BONE, AND A NEW BONE HOLE WAS DRILLED TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580908 SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD MBI ARTHROCARE CORP 1063776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other