BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT UNIVERSAL BROACH HANDLE

    MDR report key: 4100576 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28433
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 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

    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 BROACH 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 THAT 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.

    Description of Event or Problem · 1

    BROACH HANDLE WILL NOT HOLD ON TO BROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582083 SUMMIT UNIVERSAL BROACH HANDLE HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. A0709

    Patients

    Seq Age Sex Outcome Treatment
    1