BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL INSERTION HANDLE

    MDR report key: 2112735 · Received May 19, 2011

    Report

    Report Number
    1818910-2011-07117
    Event Type
    Injury
    Date Received
    May 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED. ALTHOUGH IT HAPPENED THAT THE NAIL WAS EASILY REMOVED DURING THE INVESTIGATION, THE JIG BOLT WAS JAMMED IN THE INSERTION HANDLE AND COULD NOT BE REMOVED WITHOUT BREAKING THE JIG BOLT. DAMAGE ON THE SHAFT OF THE JIG BOLT INDICATES THAT THERE WAS SOME FOREIGN MATERIAL TRAPPED WHICH CAUSED THE BINDING. THE INABILITY TO DISCONNECT THE NAIL FROM THE JIG COULD NOT BE DIRECTLY CONFIRMED SINCE ON INVESTIGATION THE NAIL READILY DISCONNECTED. IT IS POSSIBLE THAT THE JIG BOLT TO NAIL ALIGNMENT RESULTED IN A CROSS-THREADING WHICH MADE DISCONNECTION DIFFICULT. THE CAUSE OF THE JIG BOLT JAMMING IN THE INSERTER APPEARS TO BE DUE TO SOME ENTRAPPED FOREIGN MATERIAL. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME. THE COMPLAINT RATE IS STILL CONSISTENT WITH THE DFMEA. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    INTRAOPERATIVELY, IT HAS NOT BEEN POSSIBLE TO DISCONNECT THE NAIL FROM JIG AND HANDLE. THE SURGERY HAD TO BE ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL INSERTION HANDLE 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA A5GAA4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA