BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO AIRE

    MDR report key: 119481 · Received July 16, 1997

    Report

    Report Number
    MW1012075
    Event Type
    Malfunction
    Date Received
    July 16, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 7, 1997
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TOTAL KNEE REPLACEMENT, OSCILLATING SAW SHATTERED. WOUND IRRIGATED FOR DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO AIRE OSCILLATING BLADE HTW MICROAIRE SURGICAL INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR