BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI XL FEMORAL NCK ELEVATOR

    MDR report key: 6893532 · Received September 26, 2017

    Report

    Report Number
    1818910-2017-25394
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Report Date
    August 28, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    GAD
    UDI-DI
    10603295148586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 NECK RETRACTOR HANDLE BROKE OFF INTO TWO PIECES DURING SURGERY. IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673790 MI XL FEMORAL NCK ELEVATOR HIP INSTRUMENT/TRIAL GAD DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN 10603295148586

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR