BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 4823180 · Received June 6, 2015

    Report

    Report Number
    8030965-2015-10983
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Report Date
    May 8, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT OF THE DEVICE WAS NOT FUNCTIONING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT VARIOUS ADAPTERS WERE BROKEN ON THE ELECTRIC PEN DRIVE SYSTEM INCLUDING THE ELECTRIC PEN DRIVE DEVICE, THE HAND SWITCH DEVICE AND THE CABLE DEVICE. ACCORDING TO THE REPORTER, THE MOTOR ON THE ELECTRIC PEN DRIVE DEVICE WAS ACTIVATED WITHOUT THE OPERATOR GIVING THE DEVICE A START. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366740 EPD 60000 RPM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 5028

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE DEVICE