BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY

    MDR report key: 2012309 · Received February 1, 2011

    Report

    Report Number
    1822565-2011-00161
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE FRACTURE MAY BE DUE TO INCOMPLETE ASSEMBLY TO THE DRIVER INSTRUMENT WHILE IN OPERATION OR AN OFF AXIS LOADING ON THE REAMER LOCKING SCREW. THE DRIVER TABS NEED TO BE FULLY ENGAGED INTO THE SLOTS ON THE REAMER FOR PROPER TORQUE TRANSMISSION. THE DEVICE MEETS DIMENSIONAL SPECIFICATIONS WHERE MEASURE. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: AS RETURNED, THE DEVICE APPEARS TO HAVE BEEN RE-SHARPENED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SCREW WHICH HOLDS THE REAMER IN PLACE DURING USE, FRACTURED WHILE REAMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY HTO ZIMMER, INC. 61274861

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR