BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMENT

    MDR report key: 3970018 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-14755
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Report Date
    January 19, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE CUTTER COULD NOT BE INSERTED INTO THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF INJURY, SURGICAL DELAY, OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNKNOWN. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648307 6.5CM ADULT CRANI ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1