BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 1231050 · Received October 30, 2008

    Report

    Report Number
    1818910-2008-04582
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 30, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INSTRUMENT BROKE DURING SCREW INSERTION. INFO WAS REC'D INDICATING THAT PIECES OF THE INSTRUMENT FELL INSIDE THE PT. ALL PIECES BUT ONE WERE RETRIEVED; HOWEVER, IT IS NOT KNOWN IF THE ONE MISSING PIECE FELL IN THE PT OR IS SOMEWHERE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSET TPRD HEX SCDR U-JOINT 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA