BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEYLESS DRIVER

    MDR report key: 3955381 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13554
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    December 19, 2011
    Report Date
    January 23, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    K040076
    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 ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS DIFFICULT TO ATTACH TO THE MOTOR. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNK IF INJURY OR MED INTERVENTION OCCURRED. THERE IS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654065 KEYLESS DRIVER HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1