BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET RATCHET SCDR HDL

    MDR report key: 3842029 · Received May 31, 2014

    Report

    Report Number
    1818910-2014-19828
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT OF LEVER FAILURE. THE DEVICE FUNCTIONED AS INTENDED. FORWARD AND REVERSE SETTINGS WERE ABLE TO BE CHANGED AND FUNCTIONED PROPERLY. THE OVERALL CONDITION OF THE SCREWDRIVER HANDLE SUGGESTS MODERATE USAGE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    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

    PINNACLE QUICK SET SCREW - RATCHETING SCREWDRIVER HANDLE FORWARD/REVERSE LEVER FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320488 QUICKSET RATCHET SCDR HDL HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 BS0302

    Patients

    Seq Age Sex Outcome Treatment
    1