BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 5890534 · Received August 19, 2016

    Report

    Report Number
    1045834-2016-12489
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Report Date
    July 19, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF MANUFACTURE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. IT HAS BEEN UPDATED AS JUN 25, 1995. (B)(4). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. IT WAS ALSO OBSERVED THAT THE DEVICE POWER WAS LOW. THE DEVICE FAILED THE FOLLOWING PRE-TESTS: TEMPERATURE, INITIAL ROTATIONAL AND NOISE VERIFICATION. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT DAMAGE FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DATE OF MANUFACTURE IS UNKNOWN. 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 IN THE SERVICE ORDER FROM (B)(6) THAT THE MOTOR DEVICE WAS OVERHEATING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    541891 BLACKMAX-NEURO MOTOR, DRILL, PNEUMATIC - HANDPIECE HSZ DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1