BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3250034 · Received July 26, 2013

    Report

    Report Number
    1045834-2013-03667
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. IT WAS OBSERVED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR DEVICE WAS "GETTING HOT." THE DEVICE WAS BROUGHT TO STERILE PROCESSING FROM SURGERY WITH A NOTE STATING "GETTING HOT." IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY.  IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE.  IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED.  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
    350864 XMAX MOTOR DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1