BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER SHOULDER FAST

    MDR report key: 2043367 · Received March 24, 2011

    Report

    Report Number
    1818910-2011-04963
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE HEX TIP FROM THE SCREW DRIVER BROKE OFF IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEX DRIVER SHOULDER FAST 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA CE0086

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR