BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING BURR

    MDR report key: 35909 · Received August 26, 1996

    Report

    Report Number
    MW1009805
    Event Type
    Malfunction
    Date Received
    August 26, 1996
    Date of Event
    August 13, 1996
    Report Date
    August 16, 1996
    Manufacturer
    MICRO-AIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT TOTAL SHOULDER ARTHROPLASTY, THE 5.5 MM BURR USED TO DRILL SNAPPED/SHATTERED. TIP AND PIECES WERE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BURR CARBIDE SURGICAL BURR HTT MICRO-AIRE SURGICAL INSTRUMENTS, INC. NONE *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other