BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM FLUTED ACORN

    MDR report key: 3984202 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16381
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    October 4, 2011
    Report Date
    October 20, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE'S BOX HAD "WRONG CONTENT, IT IS NOT THE RIGHT ARTICLE IN THE PACKAGE ((B)(4))." THE DEVICE WAS NOT BEING USED DURING SURGERY AT THE TIME OF THE EVENT. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663849 5MM FLUTED ACORN HBC DEPUY SYNTHES POWER TOOLS D493042514

    Patients

    Seq Age Sex Outcome Treatment
    1