BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 9748450 · Received February 24, 2020

    Report

    Report Number
    1045834-2020-00346
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 10, 2020
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBB
    UDI-DI
    00845384001096
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS TRACED TO IMPROPER MAINTENANCE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE MOTOR DEVICE HAD LOW POWER, THE VANS WERE WORN AND THERE WAS A SMALL HOLE IN THE HOSE NEAR THE MUFFLER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR INITIAL ROTATIONAL SPEED. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2020. 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
    208894 BLACKMAX-NEURO INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT HBB DEPUY SYNTHES PRODUCTS LLC 00845384001096

    Patients

    Seq Age Sex Outcome Treatment
    1