BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI ANTERIOR CHISEL

    MDR report key: 7017175 · Received November 10, 2017

    Report

    Report Number
    1818910-2017-28681
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    FZO
    UDI-DI
    10603295084020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIGMA CHISEL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801022 SIGMA HP UNI ANTERIOR CHISEL KNEE INSTRUMENT/TRIAL FZO DEPUY ORTHOPAEDICS, INC. 1818910 PG1009 10603295084020

    Patients

    Seq Age Sex Outcome Treatment
    1