BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APG+ QC DRIVER SHAFT

    MDR report key: 6786297 · Received August 10, 2017

    Report

    Report Number
    1818910-2017-22615
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 13, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWR
    UDI-DI
    10603295103028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM 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 QUICK CONNECT SHAFT BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564405 APG+ QC DRIVER SHAFT SHOULDER INSTRUMENT/TRIAL HWR DEPUY ORTHOPAEDICS, INC. 1818910 PG218676 10603295103028

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR