BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, T6

    MDR report key: 6805407 · Received August 18, 2017

    Report

    Report Number
    3009996260-2017-00006
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 18, 2017
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HXX
    UDI-DI
    00840118110822
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CSD 006 CANNULATED SCREWDRIVER, T6 LOT 2014000720 PART OF GWK 100 GUIDE WIRE KIT BROKE DURING INSERTION OF A CANNULATED SCREW. THE CASE WAS UNABLE TO BE FINISHED DUE TO LACK OF A NEW SCREWDRIVER, THE CANNULATED SCREW IS NOW SITTING 1 MM ABOVE THE BONE. DUE TO THE ANGLE OF INSERTION, THE K-WIRE WAS BENT. WHEN TRYING TO REMOVE THE K-WIRE, THE K-WIRE BECAME STUCK AND BROKE AT THE END. THE K-WIRE WAS UNABLE TO BE REMOVED AND REMAINS WITHIN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585259 SCREWDRIVER, T6 SCREWDRIVER, GUIDEWIRE HXX FLOWER ORTHOPEDICS 1704220015 00840118110822

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R