BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 SHOULDER PLATE 3 HOLE RIGHT

    MDR report key: 2090720 · Received April 29, 2011

    Report

    Report Number
    1818910-2011-07477
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS ISSUE FOR BOTH PROVIDED PRODUCT CODES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION 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 INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE SHORT DRILL BIT GOT STUCK IN THE PLATE, EXTENDING THE CASE FOR 90 MINUTES AND REQUIRING THE SURGEON TO TAKE THE WHOLE PLATE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 SHOULDER PLATE 3 HOLE RIGHT 87LXT LXT DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention