BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT UNIVERSAL BROACH HANDLE

    MDR report key: 4102808 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28523
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE RETURNED HANDLE WAS FUNCTIONALLY TESTED WITH A DEPUY RETAINED BROACH AND ASSEMBLED/DISASSEMBLE AND HELD THE BROACH FIRMLY. THE OVERALL CONDITION OF THE HANDLE SUGGESTS HEAVY USAGE. A COMPLAINT DATABASE IDENTIFIED SIMILAR REPORTS AGAINST THE PROVIDED PRODUCT CODE WHICH WERE ATTRIBUTED TO PRODUCT WEAR OUT AND OR MISUSE. THE ROOT CAUSE IS ATTRIBUTED TO HEAVY USAGE/WEAR OUT DUE TO THE OVERALL CONDITION OF THE RETURNED DEVICE AND THE LENGTH OF TIME IN SERVICE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    THE BROACH HANDLE DOES NOT STAY LOCKED WHEN ATTACHED TO BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584381 SUMMIT UNIVERSAL BROACH HANDLE HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. 1818910 AK0502

    Patients

    Seq Age Sex Outcome Treatment
    1