BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3872720 · Received June 13, 2014

    Report

    Report Number
    1045834-2014-12264
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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¿S POWER WAS BROKEN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THIS WAS DUE TO MISUSE BY RUNNING THE DEVICE IN THE SAFE OR LOAD POSITION. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISUSE, ABUSE AND/OR USER ERROR. 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 THE MOTOR DEVICE ¿QUITS WHEN PRESSURE IS APPLIED TO THE BURR¿. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES, MEDICAL INTERVENTIONS OR PROLONGED HOSPITALIZATIONS REPORTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, THE REPORTER CLARIFIED 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
    349598 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER DEVICE