BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY REAMER SHAFT

    MDR report key: 16784092 · Received April 21, 2023

    Report

    Report Number
    16784092
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    August 27, 2010
    Report Date
    August 30, 2010
    Manufacturer
    DEPUY SYNTHES INC.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PRIOR TO PLACEMENT, THE REAMER SHAFT CAME APART ON THE OPERATIVE FIELD. ALL PARTS WERE NOT ACCOUNTED FOR,THEREFORE, AND INTRAOPERATIVE X-RAY WAS PERFORMED WHICH RESULTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866785 DEPUY REAMER SHAFT MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female