BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 4130430 · Received September 30, 2014

    Report

    Report Number
    1045834-2014-12932
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD VIBRATION AND WAS RUNNING HOT. IT WAS DETERMINED THAT THE VIBRATION IS DUE TO THE BEARINGS BEING DESTROYED. IT WAS FURTHER DETERMINED THAT THE OVERHEATING WAS DUE TO A WORN MOTOR. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE DEVICE BEING WORN DUE TO NORMAL USE AND SERVICING OVER TIME. 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

    IT WAS REPORTED THAT DURING ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS HAD VIBRATION AND WAS RUNNING HOT. IT WAS REPORTED THAT THIS EVENT IS NOT RELATED TO SURGERY. THERE WAS NO 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
    609439 EMAX 2 MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1