BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2604013 · Received May 25, 2012

    Report

    Report Number
    2604013
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    May 24, 2012
    Report Date
    May 25, 2012
    Manufacturer
    SYNTHES, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    DURING A HIP PINNING PROCEDURE WITH CANNULATED SCREWS, A DRILL BIT BROKE OFF IN THE PATIENT DURING INSERTION BY SURGEON. THE DRILL BIT BROKE INTO SEVERAL PIECES. A PORTION OF THE DRILL BIT REMAINS BURIED IN DEEP SOFT TISSUE OF THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BIT, DRILL HTW SYNTHES, INC. 310.63 LOT # PE01109

    Patients

    Seq Age Sex Outcome Treatment
    1 *