BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 6MM

    MDR report key: 1060089 · Received June 10, 2008

    Report

    Report Number
    1818910-2008-02470
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. THE AGE OF THE INSTRUMENT COULD NOT BE DETERMINED AS THE LOT NUMBER OR VENDOR DATE CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PROD AND/OR ANY ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING SURGERY, THE DRILL BIT EXITED THE CANAL CREATING A HOLE IN THE PT'S FEMUR. THE DRILL BIT BROKE. THE SURGEON MADE A SEPARATE INCISION TO REMOVE THE TIP OF THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL 6MM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR