BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE SCORPION NEEDLE

    MDR report key: 2250771 · Received August 28, 2011

    Report

    Report Number
    2250771
    Event Type
    Malfunction
    Date Received
    August 28, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 28, 2011
    Manufacturer
    ARTHREX INC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    NEEDLE IMPROPERLY TEMPERED RESULTING IN MISFIRE OF SUTURE PASSING. ALL IN LOT WERE FOUND TO BE ABNORMAL. SURGEON HAS SEEN SAME PROBLEM AT ANOTHER SURGICENTER, SUGGESTING WIDESPREAD PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFIRE SCORPION NEEDLE NEEDLE, SUTURING HRX ARTHREX INC AR-13995N 409680A

    Patients

    Seq Age Sex Outcome Treatment
    1 *