BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2883029 · Received December 17, 2012

    Report

    Report Number
    2883029
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE OPERATIVE PROCEDURE, THE DOCTOR WAS USING A #3 KERRISON RONGEUR AND IT BROKE WHILE IN THE SURGICAL FIELD. A SCREW WAS MISSING AND THE DOCTOR WAS ABLE TO OBTAIN THE SCREW FROM THE WOUND. ALL PIECES OF INSTRUMENT WERE ACCOUNTED FOR AND GIVEN TO THE INSTRUMENT WORKROOM TO CLEAN AND GIVE TO MATERIALS COORDINATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RONGEUR, MANUAL HAE BOSS INSTRUMENTS, LTD. 70-0332 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR