BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II PA SCREWDRIVER SHAFT

    MDR report key: 3110605 · Received May 14, 2013

    Report

    Report Number
    0009617544-2013-00184
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE EVENT DESCRIPTION ONE WOULD CONSIDER THAT PRONG AT TIP OF THIS DEVICE WHICH CONNECTS WITH THE BONE SCREW HEAD SLOTS BROKE OFF. FUNCTIONAL INSPECTION: GIVEN THE PRODUCT CONDITION (ONE PRONG BROKEN), IT WOULD NO LONGER BE OPTIMALLY FUNCTIONAL FOR ITS INTENDED USE. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE PRODUCT WAS NOT RECEIVED BACK FOR EVALUATION. NO ADVERSE CONSEQUENCE WAS REPORTED FOR THE PATIENT AT THIS TIME. THE EVENT REPORTS THAT THE SHAFT WAS BROKEN DURING REMOVAL OF SCREW SUPPORTING POTENTIAL CANTILEVER EFFORTS PROVIDED ON THE PRONGS. ADDITIONALLY, BASED ON THE EVENT DESCRIPTION, THERE SEEMED TO BE A LOT OF BONY IN GROWTH AROUND THE SCREW AND IT PROBABLY TOOK A LARGE AMOUNT OF TORQUE TO LOOSEN UP SCREWS SUPPORTING THAT HIGH LOADS WITH POTENTIAL CANTILEVER WAS APPLIED TO THE DEVICE. HENCE, IT IS BELIEVED THAT SUCH AN EVENT WOULD BE THE RESULT OF THE CONDITION OF USE AND NOT THE FACT OF A PRODUCT DISCREPANCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IN A HARDWARE REMOVAL CASE THE XIA 2 DRIVER HAD A PRONG BREAK OFF. THERE SEEMED TO BE A LOT OF BONY IN GROWTH AROUND AND THREW THE SCREW. IT TOOK A GOOD AMOUNT OF TORQUE TO LOOSEN UP SCREWS. INSPECTED REMOVED SCREWS NEXT DAY FOR BROKEN PRONG AND WAS UNSUCCESSFUL OF LOCATING IT. NOTIFIED HOSPITAL AND DOCTORS PA. DOCTOR'S PA STATED HE SEEMS TO REMEMBER THEN FINDING A BROKEN PIECE AND PUTTING IT ON BACK TABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IN A HARDWARE REMOVAL CASE THE XIA 2 DRIVER HAD A PRONG BREAK OFF. THERE SEEMED TO BE A LOT OF BONY IN GROWTH AROUND AND THREW THE SCREW. IT TOOK A GOOD AMOUNT OF TORQUE TO LOOSEN UP SCREWS. INSPECTED REMOVED SCREWS NEXT DAY FOR BROKEN PRONG AND WAS UNSUCCESSFUL OF LOCATING IT. NOTIFIED HOSPITAL AND DOCTORS PA. DOCTORS PA STATED HE SEEMS TO REMEMBER THEN FINDING A BROKEN PIECE AND PUTTING IT ON BACK TABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213296 XIA II PA SCREWDRIVER SHAFT SCREWDRIVER LXH STRYKER SPINE-FRANCE 07D485

    Patients

    Seq Age Sex Outcome Treatment
    1