BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED GUIDEWIRE K-WIRE

    MDR report key: 11921932 · Received June 1, 2021

    Report

    Report Number
    MW5101658
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 26, 2021
    Report Date
    May 28, 2021
    Manufacturer
    INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR. WAS SLIDING THE SCREW OVER THE GUIDEWIRE AND PULLED OUT THE K-WIRE AND STATED THIS SCREW PLACE DOESN'T FEEL RIGHT. DR. TOOK AN X-RAY AND SAW THERE WAS A PIECE OF K-WIRE IN THE PATIENT VERTEBRAE. HE DETERMINED IT WOULD CAUSE MORE HARM TO TRY TO REMOVE THE PIECE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807577 THREADED GUIDEWIRE K-WIRE PIN, FIXATION, THREADED JDW INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS Z16113001 040320

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other