BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDED TIBIA JIG COMPLETE

    MDR report key: 1213709 · Received October 21, 2008

    Report

    Report Number
    1818910-2008-04601
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE JIG DOES NOT STAY LOCKED IN THE CENTER POSITION. THIS CAUSED A 20 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDED TIBIA JIG COMPLETE 87LXH LXH DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR