BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO LOW PRESSURE

    MDR report key: 8864370 · Received August 6, 2019

    Report

    Report Number
    1045834-2019-54246
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    June 21, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBB
    UDI-DI
    00845384001102
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER DEVICE USE WHICH IS USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD LOW POWER AND THE HOSE WAS DAMAGED / HAD A CUT. THE DEVICE ALSO FAILED PRETEST FOR INITIAL ROTATIONAL SPEED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS IN NEED OF REPAIR. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659028 BLACKMAX-NEURO LOW PRESSURE MOTOR, DRILL, PNEUMATIC - HANDPIECE HBB DEPUY SYNTHES PRODUCTS LLC 00845384001102

    Patients

    Seq Age Sex Outcome Treatment
    1