BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR EXTRACTOR

    MDR report key: 2991539 · Received March 6, 2013

    Report

    Report Number
    0002249697-2013-00925
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. FUNCTIONAL INSPECTION INDICATES THE DEVICE IS FUNCTIONALLY ACCEPTABLE. SOME ROTATIONAL DAMAGE WAS OBSERVED ON THE SHAFT. IT IS POSSIBLE SOME DEBRIS GOT STUCK BETWEEN THE SHAFT AND HOUSING WHILE THE DEVICE WAS IN USE. NO DEBRIS WAS OBSERVED ON THE RETURNED DEVICE. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE RETURNED DEVICE IS FULLY FUNCTIONAL. IF THE ADDITIONAL INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTION HEAD (BLACK PART) OF THE FEMORAL HOLDER WAS LOCKED ON THE ANGLE WITH THE FEMORAL COMPONENT, SO THE FEMORAL COMPONENT COULD NOT BE HELD PROPERLY. NOW, IMPACTION HEAD IS PUT IN PROPER POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPACTION HEAD (BLACK PART) OF THE FEMORAL HOLDER WAS LOCKED ON THE ANGLE WITH THE FEMORAL COMPONENT SO THE FEMORAL COMPONENT COULD NOT BE HELD PROPERLY. NOW, IMPACTION HEAD IS PUT IN PROPER POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95309 FEMORAL IMPACTOR EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH RD5N401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other