BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL IMPACTOR

    MDR report key: 3844143 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-01991
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE EVENT WAS CONFIRMED. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. 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 HAVE BEEN (B)(4) OTHER EVENTS. A MATERIAL ANALYSIS WAS PERFORMED, CONCLUDING: THE HEAD OF THE FEMORAL IMPACTOR BROKE FROM REPEATED IMPACT LOADS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPACTING IN THE FEMUR, THE SURGEON HANDED THE IMPACTOR BACK TO THE TECHNICIAN AND THE HEAD OF THE IMPACTOR BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPACTING IN THE FEMUR, THE SURGEON HANDED THE IMPACTOR BACK TO THE TECHNICIAN AND THE HEAD OF THE IMPACTOR BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321982 FEMORAL IMPACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH C2T02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other