BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4MM EXTRA COARSE DIAMOND BALL

    MDR report key: 3984239 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-11524
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    April 1, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K113476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED 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. REF: (B)(4).

    Description of Event or Problem · 1

    DEVICE RECEIVED FROM (B)(6) STATING THERE WAS DEBRIS IN STERILE POUCH. THE DEVICE WAS NOT BEING USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663854 4MM EXTRA COARSE DIAMOND BALL HBE DEPUY SYNTHES POWER TOOLS D513043070

    Patients

    Seq Age Sex Outcome Treatment
    1