BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 661444 · Received January 6, 2006

    Report

    Report Number
    2020601-2006-00001
    Event Type
    Injury
    Date Received
    January 6, 2006
    Date of Event
    December 8, 2005
    Report Date
    January 6, 2006
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MICROAIRE 1600-962TNS-WIRE WAS BEING INSERTED IN A PATIENT, WHEN IT ALLEGEDLY BROKE THREE TIMES INSIDE THE PATIENT. THE INSTRUMENT IN USE AT THE TIME OF THE ALLEGED INCIDENT WAS REPORTED TO BE A 3M MINI-DRIVER (NON MICROAIRE PRODUCT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE 9" THREADED K-WIRE .062" DIAMETER HTY MICROAIRE SURGICAL INSTRUMENTS, LLC 1600-962TNS 0805101917

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other