BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4MM X 12.8MM FLUTED ROUTER

    MDR report key: 3984129 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14103
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    September 9, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE IS CURRENTLY UNDERGOING EVAL. ONCE THE EVAL HAS BEEN COMPLETED OR IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAS A "DEBRIS IN STERILE PACKAGE" ISSUE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNK IF THERE WAS ANY INJURY OR MEDICAL INTERVENTION WHICH OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663108 1.4MM X 12.8MM FLUTED ROUTER HBC DEPUY SYNTHES POWER TOOLS E213050576

    Patients

    Seq Age Sex Outcome Treatment
    1