BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE 4M TO CONSOLE FOR EPD

    MDR report key: 3914257 · Received July 3, 2014

    Report

    Report Number
    8030965-2014-10339
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. VISUAL AND FUNCTIONAL ASSESSMENTS WERE PERFORMED AND THE DEVICE PASSED ALL MANUFACTURE'S SPECIFICATIONS. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A PRODISC SURGERY AT LEVEL C4-5, IT WAS DISCOVERED THAT THE ELECTRIC PEN DRIVE DEVICE AND CABLE FOR CONSOLE DEVICE WOULD NOT POWER ON WHILE IN USE WITH AN ATTACHMENT DEVICE, CUTTER DEVICE, AND A HAND CONTROL DEVICE. ACCORDING TO THE REPORT, THE DEVICE WAS CHECKED BEFORE SURGERY AND WAS WORKING PROPERLY. AS A RESULT, THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH THE SPARE DEVICE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    391193 CABLE 4M TO CONSOLE FOR EPD INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 1795320

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR CUTTER DEVICE| HAND CONTROL DEVICE| ATTACHMENT DEVICE| ELECTRIC PEN DRIVE DEVICE