BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3203803 · Received July 3, 2013

    Report

    Report Number
    1045834-2013-02671
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND IT WAS OBSERVED THAT THE UNIT FAILED TEMPERATURE AND ROTATIONS PER MINUTE (RPM) SPECIFICATIONS. THEREFORE THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO A FAILURE OF THE INTERNAL MOTOR OR MECHANICAL COMPONENTS DUE TO EXCESSIVE FORCE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CHECK IT WAS OBSERVED THAT THE HAND PIECE DEVICE "GETS HOT, SMOKES, AND HAS LOW ROTATIONS PER MINUTE (RPM'S)." THE DEVICE WAS NOT USED IN SURGERY. IT WAS UNKNOWN IF THE THERE WERE DELAYS TO THE SCHEDULED SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THE REPORTER STATED THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THE REPORTER WAS UNABLE TO DETERMINE THE PRECISE DATE OF THIS EVENT, BUT WAS ABLE TO CONFIRM THAT THE EVENT DID OCCUR IN 2013. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304523 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC-HANDPIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1