BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM X 16MM FLUTED ROUTER

    MDR report key: 3981619 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16171
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    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 ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT 2 OF 2. REPORT RECEIVED FROM (B)(6) STATING THAT THERE WAS DEBRIS IN THE STERILE PACKAGING. THE DEVICE WAS NOT BEING USED IN SURGERY. ITS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663665 1.85MM X 16MM FLUTED ROUTER HBC DEPUY SYNTHES POWER TOOLS F063061753

    Patients

    Seq Age Sex Outcome Treatment
    1