BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSS KERRISON

    MDR report key: 439138 · Received January 24, 2003

    Report

    Report Number
    439138
    Event Type
    Malfunction
    Date Received
    January 24, 2003
    Date of Event
    June 19, 2002
    Report Date
    August 1, 2002
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    GXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING 1 MILLIMETER BOSS KERRISON DURING CRANIOTOMY THE TIP BROKE OFF. UNABLE TO LOCATE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSS KERRISON BONE PUNCH GXJ BOSS INSTRUMENTS, LTD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other