BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3140702 · Received May 31, 2013

    Report

    Report Number
    1045834-2013-02246
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY SNYTHES 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 MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS EVALUATED AND PASSED THE ACCEPTANCE TEST. THE REPORTED CONDITION WAS NOT DUPLICATED. THE REPORTED CONDITION WAS NOT 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 REGARDING A MOTOR DEVICE IN WHICH, DURING A LUMBAR LAMINECTOMY, AND E8 ERROR CODE WAS OBSERVED. ACCORDING TO THE REPORT, THE USER PERFORMED TROUBLE SHOOTING BY TURNING THE DEVICE ON AND OFF. THE E8 ERROR CODE DID NOT APPEAR FOR THE REMAINDER OF THE PROCEDURE. THERE WERE NO DELAYS IN SURGERY REPORTED AS THE CODE WAS RESOLVED QUICKLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241865 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC- HANDPIECE HBC DEPUY SNYTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1