BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 4180693 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14656
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 13, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD NO ROTATION, THE HOSING PINS WERE LOOSE AND THERE WAS MOTOR RUB. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE CAUSE OF THE LOOSE HOUSING PINS WAS DUE TO LOCTITE BREAKDOWN DURING STERILIZATION. IT WAS DETERMINED THAT THE CAUSE OF THE MOTOR RUB AND NO ROTATION WAS DETERMINED TO BE DUE TO BROKEN VANES. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM USE AND SERVICING. 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 PRIOR TO SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS OBSERVED THAT THE DEVICE HAD NO ROTATION. THERE WERE NO DELAYS TO A SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. 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
    662979 XMAX MOTOR DRILL, SURGICAL, ENT (PNEUMATIC) - HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1