BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-CONDL CHISEL 8X10X7 3/4 IN

    MDR report key: 6965114 · Received October 20, 2017

    Report

    Report Number
    1818910-2017-27072
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    September 20, 2017
    Report Date
    September 20, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    FZO
    UDI-DI
    10603295122715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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 TIP FRACTURED OFF AND NOTHING LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745270 IN-CONDL CHISEL 8X10X7 3/4 IN GENERAL/MISC INSTRUMENT FZO DEPUY ORTHOPAEDICS, INC. 1818910 SO2017765 10603295122715

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR