BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.55MM X 10MM FLUTED TWIST DRL

    MDR report key: 3131633 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02874
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A CRANIOTOMY ON (B)(6) 2013, A PART OF THE CUTTING BURR BROKE AND FELL DOWN IN THE CRANIUM. THE DOCTOR CLOSED THE REMAINING PIECE IN THE PATIENT. THE OPERATION STAFF FOUND THE DRILL BIT OF A FLUTED TWIST DRILL WAS BROKEN AFTER THE CRANIOTOMY. THE RESIDUE OF THE BROKEN DRILL BIT IN THE SKULL WAS IDENTIFIED BY CT IMAGING. THE METAL COMPOSITION OF THE DRILL BIT WAS IDENTIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235854 1.55MM X 10MM FLUTED TWIST DRL HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1