BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH HANDLE

    MDR report key: 2875164 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83812
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 11, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    FROM THE COMMUNICATED ELEMENTS, NO ANALYSIS COULD BE CARRIED OUT BECAUSE NO SUFFICIENT INFORMATION WAS PROVIDED (NO PRODUCT RETURNED, NO BATCH NUMBER). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    BROACH AND HANDLE (OLD STYLE WITH THE FEMALE ADAPTOR ON THE BROACH) HAD TOGGLE BETWEEN THEM RESULTING IN IT BEING NEARLY IMPOSSIBLE TO REMOVE THE BROACH FROM THE FEMUR. THIS TOGGLE WAS NOT SEEN BEFORE THE CASE. AFTER A 2 HOUR DELAY AND A LOT OF HELP FROM A THE CORAIL EXTRACTION SET AND MOORLANDS SLAP HAMMER THE BROACH WAS REMOVED AND THE PATIENT HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROACH HANDLE DEPUY MANUAL INSTRUMENT LXH DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other