BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRIGHT DRILL BIT

    MDR report key: 1798700 · Received July 23, 2010

    Report

    Report Number
    MW5017038
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    April 6, 2010
    Report Date
    June 11, 2010
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY TO REVISE PREVIOUS RIGHT TALONAVICULAR AND SUBTALAR ARTHODESIS, TIP OF DRILL BIT BROKE OFF IN PT'S FOOT. SURGEON DETERMINED THAT THE TIP COULD BE LEFT IN PLACE. DEAR SIR: WE HAVE RECENTLY RECEIVED THE ATTACHED INFO FROM (B)(6) HOSPITAL. THE PRODUCT IN THIS INCIDENT WAS NOT MANUFACTURED BY WRIGHT MEDICAL TECHNOLOGY. THE PRODUCT WAS MANUFACTURED BY AAP IMPLANTATE AG IN (B)(4). THE MEDWATCH 3500A HAS BEEN FORWARDED TO (B)(4) AT AAP IMPLANTATE AG. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT DRILL BIT DRILL BIT HTW WRIGHT MEDICAL IW707522

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR