BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3242397 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04530
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES USA
    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE BATTERY HANDPIECE WAS NOT WORKING DURING A PROCEDURE ON (B)(6) 2013. THE CABLE AND ATTACHMENTS WERE TESTED SEPARATELY AND FOUND TO BE FUNCTIONING AS NORMAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342907 EPD 60000 RPM HWE SYNTHES USA SER.NR. 1523

    Patients

    Seq Age Sex Outcome Treatment
    1