BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED DRIVER

    MDR report key: 6211026 · Received December 28, 2016

    Report

    Report Number
    3009996260-2016-00006
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 7, 2016
    Manufacturer
    FLOWER ORTHOPEDICS CORP.
    Product Code
    HXX
    UDI-DI
    00840118110822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GWK 100 CANNULATED DRIVER BROKE DURING IPJ FUSION. THE CANNULATED DRIVER WAS INSERTING A 20 MM CANNULATED SCREW OVER THE GUIDEWIRE WHEN THE CANNULATED DRIVER TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860742 CANNULATED DRIVER SCREWDRIVER HXX FLOWER ORTHOPEDICS CORP. 00840118110822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other