BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITST ONE-PIECE SLIDING NAIL CAP

    MDR report key: 3023241 · Received February 27, 2013

    Report

    Report Number
    1822565-2013-00398
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 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 NAIL CAP PLUG CAME OFF OF 2 NAIL CAPS. THE SURGEON USED ONE NAIL CAP WITHOUT THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85328 ITST ONE-PIECE SLIDING NAIL CAP HSB ZIMMER, INC. 62142113

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR CATALOG #00225900700, LOT #62142113| IMPLANT:| ITST ONE-PIECE SLIDING NAIL CAP: