BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CEPHALOMEDULLARY TARGETING GUIDE

    MDR report key: 1833777 · Received September 9, 2010

    Report

    Report Number
    1822565-2010-00670
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 CM NATURAL NAIL GUIDE AND DRILL GUIDE WOULD NOT CORRECTLY LINE UP WITH THE NAIL CAUSING A 1 HOUR EXTENSION IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CEPHALOMEDULLARY TARGETING GUIDE TRAUMA INSTRUMENT LXH ZIMMER, INC. 61498270

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other ZNN CEPHALOMEDULLARY LAG SCREW PIN SLEEVE:| CATALOG# 00249004310, LOT# 61310983