BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3944251 · Received July 18, 2014

    Report

    Report Number
    1045834-2014-12450
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 2, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD A HOLE IN THE HOSE BY THE MUFFLER AND HAD NO ROTATION. IT WAS DETERMINED THAT THE HOLE WAS MOST LIKELY CAUSED BY THE USER INSERTING/REMOVING THE MUFFLER FROM THE AUTOLUBE DEVICE INCORRECTLY. IT WAS DETERMINED THAT THE DEVICE NOT ROTATING WAS MOST LIKELY DUE TO THE BLADES IN THE MOTOR BEING BROKEN AND NOT ALLOWING THE SPINDLE TO ROTATE IN THE CYLINDER OF THE MOTOR. THEREFORE, THE REPORTED CONDITIONS WERE CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT DAMAGE CAUSED BY MISUSE / ABUSE AND POSSIBLY USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    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 PRIOR TO SURGERY, IT WAS OBSERVED THE MOTOR DEVICE WOULD NOT TURN AND THERE WAS A POSSIBLE LEAK. THE REPORTER DID NOT SPECIFY WHAT KIND OF LEAK. THERE WERE NO DELAYS TO THE SCHEDULED SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    422192 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1