BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.15MM X 22MM SPIRAL ROUTER

    MDR report key: 3873741 · Received November 27, 2013

    Report

    Report Number
    1045834-2013-16430
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Report Date
    June 22, 2014
    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 AND EVALUATED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE CUSTOMER'S COMPLAINT OF PACKAGING DEFECTS COULD NOT BE CONFIRMED. VISUAL INSPECTION CRITERIA ARE "NO LOOSE FOREIGN MATERIAL (LFM) WHEN INSPECTED AT 1X MAGNIFICATION". NO LFM COULD BE FOUND ON DEVICE WHEN INSPECTED AT 10X MAGNIFICATION. ALSO, THE PACKAGE IS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEAL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT 4 OF 6. REPORT RECEIVED FROM JAPAN STATING THAT THE DEVICE WAS RETURNED DUE TO ¿RETURNED PRODUCT UNUSED ¿ INCOMING ORDER FAILED DISTRIBUTOR'S INSPECTIONS¿. THE DEVICE WAS NOT BEING USED DURING SURGERY AND NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619617 2.15MM X 22MM SPIRAL ROUTER HBC HBC DEPUY SYNTHES POWER TOOLS E473057911

    Patients

    Seq Age Sex Outcome Treatment
    1