BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CM ADULT CRANI ATTACHMT

    MDR report key: 3962840 · Received June 13, 2014

    Report

    Report Number
    1045834-2013-16457
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED, AND DURING SERVICE THE NEUROTIP WAS FOUND TO BE DAMAGED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT SERVICE WAS REQUIRED FOR THE DEVICE. DURING SERVICE, THE NEUROTIP OF THE DEVICE WAS NOTED TO BE DAMAGED. IT IS KNOWN THAT THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350823 6.5 CM ADULT CRANI ATTACHMT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1