BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR EXTRACTOR

    MDR report key: 2964557 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00700
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MECHANICAL JAMMING INVOLVING A FEMORAL IMPACTOR EXTRACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS REPORT CONCLUDED THAT GOUGING WAS FOUND BETWEEN THE ROTATING SHAFT AND THE MAIN HOUSING OF THE INSTRUMENT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. MEDICAL RECORDS EVALUATION NOT PERFORMED BECAUSE NO PATIENT INFORMATION OR ADVERSE CONSEQUENCES WERE REPORTED. NO FURTHER PATIENT INFORMATION WAS PURSUED AS PATIENT FACTORS ARE NOT BELIEVED TO HAVE CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED ONE SIMILAR EVENT FOR THE REPORTED LOT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE INVESTIGATION CONCLUDED THAT MECHANICAL JAMMING WAS CAUSED BY GOUGING BETWEEN THE ROTATING SHAFT AND THE MAIN HOUSING OF THE INSTRUMENT. THIS GOUGING WAS CONSISTENT WITH A THIRD BODY GOUGING BUT NO EVIDENCE IDENTIFYING THE SOURCE OF THIRD BODY WAS DISCOVERED. THE GOUGING CAUSED METAL DEFORMATION CREATING THE INCREASED DIFFICULTY IN TURNING THE SHAFT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED.

    Description of Event or Problem · 1

    CUSTOMER HAS REPORTED THAT DURING A ROUTINE USE OF THE ITEM, SURGEON NOTED HOW THE PRODUCT WAS GETTING HARDER TO USE.

    Description of Event or Problem · 1

    CUSTOMER HAS REPORTED THAT DURING A ROUTINE USE OF THE ITEM, SURGEON NOTED HOW THE PRODUCT WAS GETTING HARDER TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68656 FEMORAL IMPACTOR EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH RD6A119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other