BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX PUSHLOCK 4.5 MM X 1 8.5MM

    MDR report key: 1202087 · Received October 10, 2008

    Report

    Report Number
    MW5008615
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ARTHREX, INC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO DRS WERE PLACING THE PUSHLOCKS IN THE BONE, AND WHEN USING THE MALLOT, THE TIPS BROKE OFF OF TWO OF THE PUSH LOCKS. APPROX 2MM OF THE TIP REMAINED IN THE PT OF EACH PUSH LOCK, BUT THE REST WAS REMOVED AND UNABLE TO BE USED. NEW IMPLANTS WERE OPENED. THE ONLY HARM TO THE PT WAS THE EXTRA LITTLE PIECE OF IMPLANT THAT WAS LEFT IN THE BONE SINCE IT BROKE OFF. UNSURE IF IT WAS USER ERROR OR DEFECTIVE PRODUCT. WE CONTINUED THE CAUSE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX PUSHLOCK 4.5 MM X 1 8.5MM NONE MBI ARTHREX, INC AR-1922PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability