BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST ONE-PIECE NAIL CAP

    MDR report key: 3151342 · Received May 30, 2013

    Report

    Report Number
    1822565-2013-00881
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON COULDN'T INSERT THE NAIL CAP STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238473 ITST ONE-PIECE NAIL CAP HSB ZIMMER, INC. 62164334

    Patients

    Seq Age Sex Outcome Treatment
    1 ITST ONE-PIECE LOCKING NAIL CAP, CAT #00225900810,| LOT #61023341