BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHESIS DRIL BIT

    MDR report key: 7024259 · Received November 13, 2017

    Report

    Report Number
    7024259
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 23, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SYNTHES, INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF IN PATIENT'S BONE. DOCTOR WAS UNABLE TO RETRIEVE IT, WOULD HAVE CAUSED MORE DAMAGE WITH ATTEMPTED REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803858 SYNTHESIS DRIL BIT HTW SYNTHES, INC 03.130.200 F-220179

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other NOT APPLICABLE.