BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3142549 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02580
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 1, 2012
    Report Date
    May 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    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. ADDITIONAL CLASSIFICATION CODES DZI, ERL, HBE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 SURGERY ON (B)(6) 2012, THE ELECTRIC PEN DRIVE STOPPED WORKING WHILE BURRING. AS A RESULT, THE SURGEON WAS UNABLE TO DO THE CRANIOTOMY, PERFORATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243740 EPD 60000 RPM HWE SYNTHES GMBH 3736

    Patients

    Seq Age Sex Outcome Treatment
    1