BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 4110342 · Received September 23, 2014

    Report

    Report Number
    1045834-2014-12940
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION WITH AN UNSPECIFIED MALFUNCTION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE DISPLAYED AN E2 ERROR MESSAGE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE MOTOR DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DISCOVERED THAT THE DEVICE DISPLAYED AN E2 ERROR. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592604 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1