BEUDAMED
    FDA Adverse Event Summary report: N

    CHISEL BLADE

    MDR report key: 2032223 · Received February 25, 2011

    Report

    Report Number
    2032223
    Date Received
    February 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    SYNTHES
    Product Code
    FZO
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING A DISPOSABLE TYPE CHISEL TO REMOVE THE HUMERAL HEAD. THE CHISEL BROKE IN TWO PIECES; THE HEAD OF THE CHISEL BROKE. BOTH PIECES WERE RECOVERED. THIS IS A REUSABLE INSTRUMENT. THE DEVICE WAS BEYOND REPAIR AND WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHISEL BLADE CHISEL, SURGICAL, MANUAL FZO SYNTHES 399.570 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR