BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60''000 RPM

    MDR report key: 2996464 · Received March 11, 2013

    Report

    Report Number
    2520274-2013-01360
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 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 CODES - DZI, ERL, HBE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED 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: BAD FUNCTION. ON (B)(6) 2013, DURING AN OSTEOTOMY, THE E-PEN STOPPED AT THE BEGINNING. AT THE BEGINNING OF THE SURGERY THE E-PEN WAS ASSEMBLED CORRECTLY AND WORKED FOR A FEW SECONDS DURING TESTING. HOWEVER, WHEN IT CAME THE TIME FOR THE OSTEOTOMY IT WOULD NOT START, WITH AND WITHOUT THE ADAPTERS. IT WAS REPORTED THERE WAS NO RISK TO THE PATIENT. THE SURGERY WAS PROLONGED WHILE WAITING FOR ANOTHER E-PEN TO BE ARRANGED AND ASSEMBLED, WHICH MEANT MORE TIME UNDER ANESTHESIA. IT WAS ALSO NOTED THE E-PEN WAS PREVIOUSLY SERVICED BY A TECHNICIAN BUT IT DID NOT WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101383 EPD 60''000 RPM HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1