BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 461331 · Received May 21, 2003

    Report

    Report Number
    2020601-2003-00001
    Event Type
    Injury
    Date Received
    May 21, 2003
    Date of Event
    March 27, 2003
    Report Date
    May 15, 2003
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MICROAIRE RECEIVED A REPORT FROM A USER FACILITY THAT A MICROAIR KIRSCHNER WIRE (K-WIRE) BROKE WHEN THE PHYSICIAN WAS DRILLING A HOLE IN THE FEMORAL CONDYL PERCUTANEOUSLY. THE WIRE BROKE-OFF BENEATH THE SKIN AND THE PHYSICIAN WAS ABLE TO RETREIVE THE PIECE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE KIRSCHNER WIRE WITH WIRE GUIDE HXI MICROAIRE SURGICAL INSTRUMENTS, INC. 1600-023 120162119

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention