BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS BL 1IN STABLECUT NEW STR

    MDR report key: 1111866 · Received August 13, 2008

    Report

    Report Number
    1818910-2008-03050
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED BLADE CONFIRMED ONE OF THE TEETH BROKE OFF. THE CAUSE IS ATTRIBUTED TO MISUSE, AS IT APPEARS THE BLADE HAS BEEN USED SEVERAL TIMES. THIS INSTRUMENT IS A SINGLE USE ITEM AND IS CLEARLY ETCHED WITH THE SINGLE USE SYMBOL. THE AGE OF THE PRODUCT COULD NOT BE DETERMINED, AS THE LOT NUMBER OF VENDOR DATE CODE WAS NOT PROVIDED AND IS NOT ETCHED ON THE PRODUCT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW 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 TOOTH OF THE SAW BLADE CHIPPED OFF CAUSING A 20 MINUTE DELAY TO THE SURGICAL PROCEDURE. ALL PIECES WERE RETRIEVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS BL 1IN STABLECUT NEW STR 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR