BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON DEPUY - ORTHOPAEDICS. INC

    MDR report key: 11731420 · Received April 21, 2021

    Report

    Report Number
    11731420
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 15, 2021
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CLOSED ELBOW PROCEDURE THE DRILL BIT BROKE OFF AND LODGED INTO THE BONE. X-RAY REVEALED LOCATION OF DRILL BIT IN BONE AND DETERMINED TO BE "NON­ RETRIEVABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596171 JOHNSON & JOHNSON DEPUY - ORTHOPAEDICS. INC SYNTHES - SWISS HTW SWISS 320.062 85P2044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other