BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3894573 · Received June 25, 2014

    Report

    Report Number
    1045834-2014-12295
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 10, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. DURING TESTING THE DEVICE WAS FOUND TO HAVE LOW RPM AND THE AIR PUMP STAYS ON WHICH CAUSES A SLIGHT VIBRATION IN THE HOSE. THE REPORTED CONDITIONS WERE CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MOTOR DEVICE OPERATED FOR LESS THAN ONE MINUTE, THEN SLOWED AND STOPPED IN THE SPACE OF A FEW SECONDS. A CODE E6 WAS DISPLAYED ON THE CONSOLE DEVICE. ACCORDING TO THE REPORT, EVEN AFTER THE PEDAL WAS NO LONGER DEPRESSED, THE WIRING THAT WAS EXITING THE HAND PIECE COULD BE FELT TO BE VIBRATING. THE REPORTER STATED THAT THE ONLY WAY TO STOP THE VIBRATION WAS BY UNPLUGGING THE HAND PIECE FROM THE CART. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THE TYPE OF SPARE WAS NOT PROVIDED. THERE WAS PATIENT INVOLVEMENT REPORTED, PATIENT INFORMATION WAS NOT PROVIDED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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
    371653 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSOLE DEVICE