BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVAL CUTTING CARBIDE BURR, LONG

    MDR report key: 14634 · Received July 13, 1994

    Report

    Report Number
    MW1002784
    Event Type
    Other
    Date Received
    July 13, 1994
    Date of Event
    June 30, 1994
    Report Date
    July 1, 1994
    Manufacturer
    MICRO-AIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL REPAIR THE BURR BROKE OFF IN THE SURGICAL SITE. ATTEMPTS WERE MADE TO REMOVE BROKEN BURR, BUT WERE UNSUCCESSFUL. A BURR GUARD WAS UTILIZED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL CUTTING CARBIDE BURR, LONG OVAL CUTTING CARBIDE BURR, LONG HTW MICRO-AIRE SURGICAL INSTRUMENTS, INC. 119310559

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other