BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3336595 · Received September 9, 2013

    Report

    Report Number
    8030965-2013-04812
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 13, 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCTS INCLUDE DZI, ERL, AND HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, THE SURGEON TRIED TO USE AN ELECTRIC PEN DRIVE, BUT THE HANDPIECE REPEATED NORMAL AND REVERSE ROTATIONS. ANOTHER DRILL WAS USED TO FINISHED THE OPERATION. SINCE THE ELECTRIC PEN DRIVE WAS PURCHASED IN MARCH, THE DOCTOR WAS UNSURE OF THE QUALITY OF THE DEVICE. NO ARTICLE WAS RECEIVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449537 EPD 60000 RPM HWE SYNTHES GMBH SER.NO. 4822

    Patients

    Seq Age Sex Outcome Treatment
    1