BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY

    MDR report key: 2093905 · Received April 19, 2011

    Report

    Report Number
    1822565-2011-00969
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. AS RETURNED, THE REAMER SHAFT HAS BROKEN AND REMAINS IN THE CANNULATED STRAIGHT DRIVER. THE REAMER HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 1 YEAR. THIS TYPE OF FAILURE MAY OCCUR IF THE THREADED PEG OF THE REAMER IS NOT COMPLETELY AND SECURELY SCREWED INTO THE DRIVER. THIS SITUATION MAY ALLOW THE REAMING TORQUE AND ANY BENDING FORCES TO BE APPLIED TO THE THREADED PEG INSTEAD OF BEING TRANSMITTED BY THE REAMER BODY'S FACETS TO THE TABS OF THE DRIVER. HOWEVER, THE EXACT CAUSE OF FAILURE CANNOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. DIMENSIONAL ANALYSIS FOUND THE PART TO BE WITHIN SPECIFICATION WHERE MEASURED. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE REAMER BROKE OFF IN THE DRIVER DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B/F GLENOID STRAIGHT SPOKE REAMER ASSEMBLY HTO ZIMMER INC 61463227

    Patients

    Seq Age Sex Outcome Treatment
    1