BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETACHABLE FLEX SHAFT

    MDR report key: 2946358 · Received February 6, 2013

    Report

    Report Number
    0002249697-2013-00578
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. IN ADDITION, INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED TO CONDUCT A COMPLETE MANUFACTURING FILE REVIEW. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. WITH THE INFORMATION PROVIDED AT THE TIME OF THE INVESTIGATION, NO EVIDENCE EXISTS TO SUGGEST ANY MANUFACTURING NON CONFORMANCES. IF THE DEVICE AND/OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DR (B)(6) WISHED THAT OUR ACETABULAR SCREW SYSTEM WAS DESIGNED BETTER. FLEXIBLE SHAFT IS TOO SHORT. HE WAS UNABLE TO PUT IN A SCREW IN THE HIP TODAY.

    Description of Event or Problem · 1

    DR. (B)(6) WISHED THAT OUR ACETABULAR SCREW SYSTEM WAS DESIGNED BETTER. FLEXIBLE SHAFT IS TOO SHORT. HE WAS UNABLE TO PUT IN A SCREW IN THE HIP TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50833 DETACHABLE FLEX SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other