BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3132914 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02448
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 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 USED FOR TREATMENT AND NOT DIAGNOSIS. THE ELECTRIC PEN DRIVE HAS BEEN DISMANTLED AND CHECKED FOR FUNCTIONING. THE INVESTIGATION HAS SHOWN THAT THE MOTOR AND THE CONTROL UNIT ARE DEFECTIVE; HEAVY RESIDUES OF DETERGENTS WERE FOUND. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THIS EPD WAS MANUFACTURED IN JUNE 2011 ACCORDING TO THE SPECIFICATIONS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE EPD FAILED DUE TO A WRONG HANDLING DURING THE REPROCESSING PROCEDURE. THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES DZI, ERL, HBE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON AN UNKNOWN DATE, AN ELECTRIC PEND DRIVE (EPD) WAS MALFUNCTIONING. REPORTEDLY, AT THE MOMENT OF CONNECTION WITH THE CABLE, THE ENGINE IMMEDIATELY STARTS TO RUN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234663 EPD 60000 RPM HWE SYNTHES GMBH SER.NR. 4057

    Patients

    Seq Age Sex Outcome Treatment
    1