BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION DRILL

    MDR report key: 1082128 · Received July 25, 2008

    Report

    Report Number
    1822565-2008-00444
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BREAKAGE MIGHT HAVE BEEN CAUSED DUE TO APPLICATION OF HIGH TORQUE ALONG WITH BENDING DEFLECTION DURING ITS USE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL CODES: THE RETURNED DRILL BIT EXHIBITS FRACTURE DAMAGE TO THE FLUTED SECTION OF THE DEVICE. THE FRACTURE OCCURRED AT APPROX 1 1/8" FROM THE DISTAL END OF THE DEVICE. THE FRACTURE LOCATION APPEARS TO BE WHERE THE RELIEF ON THE BACK SIDE OF THE CUTTING EDGES STOPS. SCANNING ELECTRON MICROSCOPY ANALYSIS INDICATED THE FRACTURE OCCURRED FROM OVERLOAD. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS CONFIRMS THE MATERIAL TO BE 455 SST. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE INTACT AND CONFORMING, INDICATION THE DEVICE WAS MFG TO SPECS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE THE DR WAS DRILLING INTO THE BONE, NEARLY AN INCH LENGTH FROM THE TIP OF THE DRILL BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION DRILL SHOULDER INSTRUMENT HSD ZIMMER, INC. NA 60749028

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR