BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM DIAMOND BALL, 15CM

    MDR report key: 3975158 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-15587
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    August 10, 2012
    Report Date
    August 16, 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 WAS EVALUATED AND THE CUSTOMER'S COMPLAINT OF PACKAGING DEFECTS COULD NOT BE CONFIRMED. VISUAL INSPECTION ACCEPTANCE CRITERIA AND "NO LOOSE FOREIGN MATERIAL (LFM) WHEN INSPECTED AT 1X MAGNIFICATION." NO LFM COULD BE FOUND ON THE DEVICE WHEN INSPECTED AT 10X MAGNIFICATION. ALSO, THE PACKAGE IS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEAL. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS RETURNED UNUSED BECAUSE IT "FAILED DISTRIBUTOR'S INSPECTIONS." DEBRIS IN STERILE PACKAGING WAS OBSERVED. THE DEVICE WAS NOT BEING USED DURING SURGERY AND NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648845 3MM DIAMOND BALL, 15CM HBC DEPUY SYNTHES POWER TOOLS E533059144

    Patients

    Seq Age Sex Outcome Treatment
    1