BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLO FX/ADV INSERTER/EXTRACTOR

    MDR report key: 4162178 · Received October 10, 2014

    Report

    Report Number
    1818910-2014-29768
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    October 9, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED A PORTION OF THE TIP BROKE OFF. PREVIOUS INVESTIGATIONS FOUND THAT IF THE TIP IS NOT SCREWED DOWN UNTIL IT IS SEATED AGAINST THE BASE OF THE EXTRACTOR (TIPS ARE SWITCHED BETWEEN A METAL AND POLY DURING SURGERY), THE IMPACT FORCE APPLIED TO THE IMPACTOR/EXTRACTOR TO SEAT THE IMPLANT CAN SHEAR THE BOLT. IN ADDITION, THE VENDOR DATE CODE AH0802 INDICATES THE INSTRUMENT WAS MANUFACTURED IN AUGUST OF 2002 AND IS OVER 12 YEARS OLD. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    INSTRUMENT TIP HAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644569 GLO FX/ADV INSERTER/EXTRACTOR SHOULDER INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. AH0802

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR