BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 MM COARSE DIAMOND BALL, STD

    MDR report key: 3983768 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-13352
    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 REPORTED CONDITION OF "DID NOT MEET DISTRIBUTOR SPECIFICATIONS" 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 2 OF 2. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE CONTAINED FOREIGN "DEBRIS IN THE STERILE POUCH." THE DEVICE WAS NOT USED DURING SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. THERE IS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663833 2 MM COARSE DIAMOND BALL, STD HBC DEPUY SYNTHES POWER TOOLS F033060263

    Patients

    Seq Age Sex Outcome Treatment
    1