BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAYENNE MEDICAL

    MDR report key: 4768863 · Received May 7, 2015

    Report

    Report Number
    MW5042651
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 7, 2015
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT TIP BROKE-OFF DURING SURGERY. EMBEDDED IN BONE, SO SURGEON INTENTIONALLY LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302526 CAYENNE MEDICAL DRILL HTW CAYENNE MEDICAL, INC. CM9324

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other