BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 878611 · Received June 1, 2007

    Report

    Report Number
    878611
    Event Type
    Malfunction
    Date Received
    June 1, 2007
    Date of Event
    May 24, 2007
    Report Date
    June 1, 2007
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING A DRILL BIT TO REPAIR A QUAD TEAR ON THIS PATIENT. THE DRILL END SNAPPED OFF AT THE BEGINNING OF THE DRILLING. THIS HAPPENED WITH THE 2.4 X 2 AND A 3.2 X 1. THE FOURTH ATTEMPT WAS SUCCESSFUL. THE TIPS OF THE DRILLS WERE NOT EMBEDDED A LOT SO THEY WERE RETRIEVED EASILY. NO METAL WAS LEFT IN THE PATIENT FROM THE DRILL BITS. THE PROCEDURE CONTINUED ON WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE DRILL BIT HTW MICROAIRE SURGICAL INSTRUMENTS, INC. 3.2MM X 127 MM 0407126606
    2 * DRILL BIT HTW MICROAIRE 2.4 MM X 127MM 0407125892
    3 MICROAIRE DRILL BIT HTW MICROAIRE 2.4MM X 127MM 0407126226

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR