BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ZIMMER TM HUMERAL DRILL BIT

    MDR report key: 1051899 · Received May 22, 2008

    Report

    Report Number
    1822565-2008-00265
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER, THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVAL SUMMARY: NO PRODUCT WAS RETURNED FOR EVAL. ALSO, NO PART NUMBERS OR LOT NUMBERS WERE PROVIDED. BREAKAGE MIGHT HAVE BEEN CAUSED DUE TO APPLICATION OF HIGH TORQUE ALONG WITH BENDING/DEFLECTION DURING ITS USE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BIT BROKE OFF INTO THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ZIMMER TM HUMERAL DRILL BIT SHOULDER INSTRUMENT HSD ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK