BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3111910 · Received May 7, 2013

    Report

    Report Number
    1045834-2013-02099
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS TESTED AND THE REPORTED CONDITION WAS DUPLICATED. EVIDENCE INDICATES THIS IS DUE TO IMPROPER HANDLING. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT "THE PIN ON THE CORD" OF THE MOTOR DEVICE WAS BENT. THE MOTOR DEVICE WAS NOT USED IN SURGERY. THERE WAS AN IDENTICAL SPARE DEVICE AVAILABLE FOR EVALUATION. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198049 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1