BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM SCREW EXTRACTOR

    MDR report key: 1172224 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-04049
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE FOUND ONE PRIOR REPORT FOR THIS PROBLEM FOR THIS PRODUCT NUMBER AND THE ROOT CAUSE APPEARED TO BE MISUSED. THE LOT NUMBER OR DATE CODE WAS NOT PROVIDED TO DETERMINE THE AGE OF THE PRODUCT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PIECE OF THE EXTRACTOR IS LODGED INTO THE SCREW, BOTH ARE STILL IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM SCREW EXTRACTOR 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR