BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON

    MDR report key: 4741856 · Received March 19, 2015

    Report

    Report Number
    4741856
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    November 14, 2014
    Report Date
    March 19, 2015
    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

    WHILE DR WAS USING A 3MM BOSS KERRISON ON AN OPERATIVE PROCEDURE, A SCREW FELL OUT AND THE INSTRUMENT FELL APART. THE SCREW WAS FOUND AND WAS REMOVED FROM THE STERILE FIELD ALONG WITH THE INSTRUMENT. THE DEVICE WAS GIVEN TO THE MATERIALS COORDINATOR. AN X-RAY WAS TAKEN AND REPORTED AS NO FOREIGN BODIES WERE SEEN AND NEGATIVE FOR FOREIGN OBJECTS, PER DR THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186183 KERRISON RONGEUR, MANUAL HAE BOSS INSTRUMENTS, LTD. 70-0332 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CARDIAC DRUGS