BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 4140839 · Received October 3, 2014

    Report

    Report Number
    1045834-2014-13040
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD NOISE, LOW ROTATIONS PER MINUTE AND FAILED THE FAILED TEMPERATURE SPECIFICATION. THE ASSIGNABLE ROOT CAUSE AS DETERMINED TO BE DUE TO MISUSE, ABUSE AND/OR USER ERROR. 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 NOISE, LOW ROTATIONS PER MINUTE AND FAILED THE FAILED TEMPERATURE SPECIFICATION. IT WAS REPORTED THAT THE EVENT WAS 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
    620671 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown