BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4MM X 12.8MM FLUTED ROUTER

    MDR report key: 3984222 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15554
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    March 31, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. RELIABILITY ENGINEERING EVALUATED THE DEVICES, AND THE REPORTED PROBLEM WAS CONFIRMED. IT WAS CONCLUDED THAT THE CUTTERS CAME INTO CONTACT WITH THE DURA GUARD DURING USE. THIS OCCURS WHEN THE CUTTER FLUTES LOAD UP WITH BONE FRAGMENTS AND CAN NO LONGER REMOVE BONE AT THE SAME RATE DUE TO LACK OF SUFFICIENT IRRIGATION, SO THE USER TENDS TO APPLY MORE (EXCESSIVE) FORCE. THE CUTTER DEFLECTS TO THE POINT WHERE CONTACT IS MADE BETWEEN THE DURA GUARD AND THE CUTTER, AND FRACTURES FROM IMPACT WITH THE DURA GUARD. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT 4 OF 4. REPORT RECEIVED FROM USA STATING THAT THE DEVICE FRACTURED WHILE TURNING THE FLAP ON THE PT DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THE DATE OF THE EVENT IS UNK. THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664420 1.4MM X 12.8MM FLUTED ROUTER HBC DEPUY SYNTHES POWER TOOLS E023043561

    Patients

    Seq Age Sex Outcome Treatment
    1 NI