BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4MM X 12.8MM FLUTED ROUTER

    MDR report key: 3983977 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-15861
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    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
    SZ
    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 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 INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT 2 OF 2. REPORT RECEIVED FROM (B)(6), STATING THE DEVICE CONTAINED FOREIGN DEBRIS IN THE STERILE POUCH. THE DEVICE WAS NOT USED DURING SURGERY. THERE WAS NO PT/USER INJURY REPORTED. THE DATE OF EVENT IS UNK. THERE IS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663058 1.4MM X 12.8MM FLUTED ROUTER HBC DEPUY SYNTHES POWER TOOLS E483058127

    Patients

    Seq Age Sex Outcome Treatment
    1