BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3984163 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16399
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA FOR SERVICING. DURING SERVICING THE DEVICE WAS FOUND TO HAVE A COSMETIC DEFECT. IT IS UNKNOWN IF THE DEVICE WAS BEING USED IN SURGERY OR IF ANY INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664055 11.0 CM LONG ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1