BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3884291 · Received June 19, 2014

    Report

    Report Number
    1045834-2014-12315
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 MET ALL MANUFACTURE'S SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. 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 PRE-SURGERY THE MOTOR DEVICE WAS OPERATING INTERMITTENTLY; IT WAS FURTHER CLARIFIED THAT ¿IF THE HANDPIECE IS TILTED TO ONE SIDE OR THE OTHER IT WILL STOP WORKING¿. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WERE NO DELAYS TO A PLANNED SURGICAL PROCEDURE. A SPARE IDENTICAL DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, 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
    360047 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1