BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.15MM X 22MM SPIRAL ROUTER

    MDR report key: 3717170 · Received November 27, 2013

    Report

    Report Number
    1045834-2013-09538
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE CUSTOMER'S COMPLAINT OF PACKAGING DEFECTS COULD NOT BE CONFIRMED. VISUAL INSPECTION ACCEPTANCE CRITERIA ARE "NO LOOSE FOREIGN MATERIAL (LFM) WHEN INSPECTED AT (B)(4) MAGNIFICATION." NO LFM COULD BE FOUND ON DEVICE WHEN INSPECTED AT (B)(4) 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 SENT.

    Description of Event or Problem · 1

    REPORT 1 OF 3 RECEIVED FROM (B)(6) STATING THAT THERE WAS DEBRIS INSIDE THE STERILE PACKAGING. THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619594 2.15MM X 22MM SPIRAL ROUTER HBC DEPUY SYNTHES POWER TOOLS F033059507

    Patients

    Seq Age Sex Outcome Treatment
    1