BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 4211954 · Received October 29, 2014

    Report

    Report Number
    1045834-2014-14685
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY, IT WAS OBSERVED THAT THE CORD OF THE MOTOR DEVICE HAD CUTS AND WIRES WERE EXPOSED. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE. THERE WERE NO SPARE DEVICES AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF EVENT WAS UNKNOWN. HOWEVER, THE REPORTER STATED THE EVENT OCCURRED IN (B)(6) 2014. 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
    693852 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1