BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3249847 · Received July 26, 2013

    Report

    Report Number
    1045834-2013-03656
    Event Type
    Malfunction
    Date Received
    July 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE DEVICE FAILED THE ROTATIONS PER MINUTE (RPMS) SPECIFICATIONS. THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO A FAILURE OF THE INTERNAL MOTOR OR MECHANICAL COMPONENTS AS A RESULT OF EXCESSIVE FORCE. 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 IT WAS OBSERVED THAT THE MOTOR DRILL DEVICE "PRODUCED LOE ROTATIONS PER MINUTE (RPMS)." IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY OR IF THE ALLEGED MALFUNCTION WAS DISCOVERED DURING PRE-CHECK.  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.  THE EXACT EVENT DATE WAS UNKNOWN. HOWEVER, THE REPORTER CLARIFIED 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
    349946 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC-HAND PIECE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1