BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DRILL BIT

    MDR report key: 1061010 · Received June 12, 2008

    Report

    Report Number
    1818910-2008-02517
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 28, 2005
    Report Date
    May 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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

    LITIGATION PAPERS STATE THAT DURING SURGERY IN 2005, THE TIP OF A DRILL BIT USED TO PLACE A SCREW BROKE AND WAS EMBEDDED INTO THE BONE OF THE PATIENT'S S1 VERTEBRAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA