BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3496258 · Received November 4, 2013

    Report

    Report Number
    3496258
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    September 24, 2013
    Report Date
    November 4, 2013
    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 OPERATIVE PROCEDURE, WHILE USING A 3MM BOSS KERRISON, THE SCREW FROM THIS INSTRUMENT FELL OUT ONTO THE STERILE FIELD. (DID NOT FALL IN WOUND). INSTRUMENT AND SCREW REMOVED FROM STERILE FIELD AND GIVEN TO MATERIALS COORDINATOR. X-RAY TAKEN AND READ AS NEGATIVE BY PHYSICIAN. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567030 * KERRISON RONGEUR HAE BOSS INSTRUMENTS, LTD. 70-0332 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR