BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES 2.0MM GUIDEWIRE

    MDR report key: 6255872 · Received January 12, 2017

    Report

    Report Number
    MW5067234
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SYNTHESS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WENT TO THE OPERATING ROOM AND HAD A CLOSED REDUCTION, INTERNAL FIXATION (OPEN TREATMENT) LEFT SUPRACONDYLAR DISTAL FEMUR FRACTURE WITH SYNTHES SUPRACONDYLAR RIVAL ANGLE PLATE AND SCREWS. A SYNTHES 2.0MM STAINLESS STEEL GUIDEWIRE TIP BROKE OFF AND IS MAINTAINED WITHIN CORTICES OF LEFT FEMUR. TIP UNABLE TO BE RETRIEVED FROM THE CORTICES OF THE LEFT FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31011 SYNTHES 2.0MM GUIDEWIRE GUIDEWIRE DQX SYNTHESS 292.652

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other