BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2MM DIAMOND BALL

    MDR report key: 3981607 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-12273
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    June 25, 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
    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 REPORTED CONDITION OF "DID NOT MEET DISTRIBUTOR'S INSPECTION" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    REPORT 4 OF 6. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS BEING RETURNED UNUSED BECAUSE "INCOMING ORDER FAILED DISTRIBUTOR'S INSPECTION." IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. IT IS KNOW THAT NO PT OR USER INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663663 2MM DIAMOND BALL HBC DEPUY SYNTHES POWER TOOLS E473058515

    Patients

    Seq Age Sex Outcome Treatment
    1