BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3 MM SQUARE SCREWDRIVER

    MDR report key: 2090731 · Received April 29, 2011

    Report

    Report Number
    1818910-2011-07405
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    SCREW DRIVER HEAD SHEERED OFF IN 2.5 LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.3 MM SQUARE SCREWDRIVER 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown