BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY IMPACT CHISEL

    MDR report key: 8222263 · Received January 4, 2019

    Report

    Report Number
    MW5082873
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 2, 2019
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    FZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMING TOTAL KNEE REVISION AND DURING THE SURGERY THE IMPACTOR CHISEL FROM DEPUY BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9828 DEPUY IMPACT CHISEL CHISEL, SURGICAL, MANUAL FZO DEPUY SYNTHES, INC. 24210010000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention