BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3984252 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16100
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    January 23, 2012
    Report Date
    February 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT FROM THE USA STATING THAT THE NURSE HATES OUR VERY THIN IRRIGATION TIP. IT BENDS VERY EASILY WHEN SHE TRIES TO SLIDE THE BLACK CLIP TO THE END AND IT GETS VERY DIFFICULT TO CLIP IT TO THE END EFFECTOR. IT IS UNK IF THE DEVICE WAS USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664041 NONE FRN DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1