BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1902206 · Received November 9, 2010

    Report

    Report Number
    9610667-2010-00013
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 21, 2010
    Report Date
    November 10, 2010
    Manufacturer
    TORNIER INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT IS A CLASS 1 REUSABLE SURGICAL TOOL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGICAL PREPARATION FOR A SHOULDER PROSTHESIS, THE DRILL BIT BROKE IN BONE. THE BROKEN TIP IS REPORTED TO REMAIN IN THE PT. THE REMAINING SEGMENT OF DRILL IS CURRENTLY AT THE CLINICAL FACILITY. RELEASE FOR EXAMINATION HAS BEEN REQUESTED. DEVICE LOT NUMBER HAS NOT BEEN REPORTED. THIS IS A REPORT OF AN UNANTICIPATED FOREIGN BODY. REFERENCE USER FACILITY REPORT 0504240000-2010-8015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER 3MM DRILL BIT HTW TORNIER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR