BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO

    MDR report key: 3963899 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-14131
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    June 8, 2011
    Report Date
    June 9, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT THE DEVICE EXPERIENCED "BURNING BONE NOT CUTTING THROUGH IT" DURING SURGERY. IT IS KNOWN THAT DEVICE WAS BEING USED DURING SURGERY HOWEVER NO PATIENT OF USER INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNKNOWN IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652897 BLACKMAX-NEURO HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1