BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM SHORT ANGLE ATTACHMENT

    MDR report key: 3963856 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-07958
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652652 7.5CM SHORT ANGLE ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1