BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRIVER SHAFT

    MDR report key: 3203192 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02210
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE CANNOT CONFIRM THE REPORTED "BREAK". THE EDGES OF THE TIP HAVE SIGNS OF MINIMAL WEAR. THE DRIVER MATES WITH A BONE SCREW WITH NO DISCREPANCIES. THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN OTHER EVENTS FOR THE LOT REFERENCED. FURTHER ANALYSIS WILL BE PERFORMED UNDER QUARTERLY TREND. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT CANNOT BE CONFIRMED AS NO FRACTURE WAS OBSERVED ON THE RETURNED DEVICE. THE TIP OF THE DEVICE SHOWED SOME SIGN OF WEAR. HOWEVER, A FUNCTIONAL ANALYSIS CONFIRMED THE DEVICE IS FULLY FUNCTIONAL. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A PRIMARY TOTAL HIP THE UNIVERSAL SCREWDRIVER HEAD IS BROKEN. NOTICED RIGHT BEFORE THE CASE BEGAN. REP HAD ANOTHER ON HAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A PRIMARY TOTAL HIP THE UNIVERSAL SCREWDRIVER HEAD IS BROKEN. NOTICED RIGHT BEFORE THE CASE BEGAN. REP HAD ANOTHER ON HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301231 UNIVERSAL DRIVER SHAFT INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other