BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSS KERRISON RONGEUR, MICRO

    MDR report key: 10074903 · Received May 19, 2020

    Report

    Report Number
    MW5094580
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    February 25, 2020
    Report Date
    May 18, 2020
    Manufacturer
    BOSS INSTRUMENTS, LTD.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STEALTH KERRISON PRODUCT BROKE APART WHEN GOING TO BE USED INITIALLY IN CASE. FOUND THAT A SCREW MISSING FROM DEVICE. PATIENT X-RAY COMPLETE AND SCREW NOT LOCATED. BELIEVED TO HAVE FALLEN OUT DURING PROCESSING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536816 BOSS KERRISON RONGEUR, MICRO RONGEUR HTX BOSS INSTRUMENTS, LTD. 70-0332P

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR