BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3250327 · Received July 26, 2013

    Report

    Report Number
    1045834-2013-03713
    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
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 DID NOT MEET SPECIFICATIONS. IT WAS OBSERVED THAT THE DEVICE DID NOT FUNCTION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE INDICATES THIS WAS DUE TO IMMERSION DURING CLEANING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE THERE WAS AN ERROR CODE OBSERVED ON THE MOTOR DEVICE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. DURING PRE-TESTING OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THE DEVICE " HAD LIQUID COMING FROM THE MOTOR, THE HANDPIECE WAS NOT WORKING AND AN ERROR CODE DISPLAYED ON THE CONSOLE". THE DEVICE WAS NOT USED IN SURGERY AS THE REPORTED CONDITION WAS DISCOVERED DURING TESTING. NO 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
    350635 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1