BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.15MM X 22MM SPIRAL ROUTER

    MDR report key: 3984216 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14884
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DETERMINED THAT THE CUTTERS CAME INTO CONTACT WITH THE DURA GUARD OF THE ATTACHMENT DURING USE, CAUSING THE REPORTED FRACTURE. THE ATTACHMENT EXHIBITED DAMAGE THAT WAS INDICATIVE OF EXCESSIVE SIDE LOADING DURING USE, AND A CUTTER THAT WAS NOT PROPERLY ASSEMBLED AND SECURED INTO THE MOTOR BEFORE USE. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA THAT DEVICE BROKE DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THE DATE OF THE EVENT IN UNK. THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664363 2.15MM X 22MM SPIRAL ROUTER HBC DEPUY SYNTHES POWER TOOLS E073046149

    Patients

    Seq Age Sex Outcome Treatment
    1 NI