BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZNN SYSTEM CEPHALOMEDULLARY TARGETING GUIDE

    MDR report key: 2012287 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00162
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 TARGETING GUIDE WAS NOT FUNCTIONING CORRECTLY DURING SURGERY. THE DRILL WOULD NOT TARGET CORRECTLY. THE LOCKING BOLT OF THE GUIDE HAD TO BE RETIGHTENED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN SYSTEM CEPHALOMEDULLARY TARGETING GUIDE HSB ZIMMER, INC. 61516707

    Patients

    Seq Age Sex Outcome Treatment
    1