BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4MM X 12.8MM FLUTED ROUTER

    MDR report key: 3984267 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15840
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    March 21, 2011
    Report Date
    March 24, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO DEPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT 2 OF 2. REPORT RECEIVED FROM (B)(6) STATING THAT DEVICE BROKE DURING USE ON CRANIAL FLAP. THER WAS NO INJURY REPORTED. IT IS UNK IF DELAY OR MEDICAL INTERVENTION OCCURRED. THE BROKEN DEVICE WAS DISPOSED AT THE TIME. REPRESENTATIVE SAMPLES WITH SAME LOT NUMBER WERE RETURNED. THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663918 1.4MM X 12.8MM FLUTED ROUTER HBC DEPUY SYNTHES POWER TOOLS D493042578

    Patients

    Seq Age Sex Outcome Treatment
    1