BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON

    MDR report key: 3363966 · Received September 23, 2013

    Report

    Report Number
    3363966
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    September 4, 2013
    Report Date
    September 23, 2013
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING A KERRISON INTRAOPERATIVELY, THE SCREW FELL OUT OF INSTRUMENT AND INTO WOUND. THE SCREW WAS REMOVED FROM WOUND BY PHYSICIAN. A X-RAY WAS TAKEN AND READ AS NEGATIVE. THE INSTRUMENT WAS REMOVED FROM OPERATIVE FIELD AND GIVEN TO MATERIALS COORDINATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480024 KERRISON INSTRUMENT, RONGUER HTX BOSS INSTRUMENTS, LTD 70-0330 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR