BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3994367 · Received August 8, 2014

    Report

    Report Number
    1045834-2014-12558
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE DEVICE MET ALL MANUFACTURE'S SPECIFICATIONS. THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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 DURING AN UNSPECIFIED SPINE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE DRILL BITS WERE WOBBLING WHEN IN USE ON THE MOTOR DEVICE. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE REPORTER DID NOT HAVE ANY INFORMATION REGARDING THE TYPE OF DRILL BITS USED. THERE WAS NO REPORTED MALFUNCTION AGAINST THE DRILL BITS. 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
    467607 EMAX 2 PLUS MOTOR MOTOR, DRILL, ELECTRIC - HANDPIECE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL BITS DEVICE