BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGLIANI/FLATOW FUKUDA TYPE RETRACTOR LARGE

    MDR report key: 2081997 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00846
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE IS FRACTURED AT THE GROOVES AROUND THE PERIMETER OF THE BLADE. THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY 4 MONTHS. THE RETURNED DEVICE HAS ONE PRONG MORE BENT, THEN, THE OTHER POSSIBLY INDICATING GREATER LEVERING ON ONE SIDE AS OPPOSED TO THE OTHER. BREAKAGE MAY HAVE BEEN CAUSED DUE TO APPLICATION OF HIGH BENDING FORCES DURING USE. EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS/ENERGY DISPERSIVE SPECTROSCOPY (EDS) ANALYSIS WAS PERFORMED. SEM ANALYSIS OF THE FRACTURED SURFACE INDICATED THE FRACTURE WAS DUE TO REPEATED LOADING. DIMENSIONAL ANALYSIS FOUND MEASUREMENTS TAKEN TO BE WITHIN SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE RETRACTOR IS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW FUKUDA TYPE RETRACTOR LARGE GAD ZIMMER, INC. 61672035

    Patients

    Seq Age Sex Outcome Treatment
    1