BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR L SCREWDRIVER MODULAR FLEXIBLE

    MDR report key: 3053182 · Received April 11, 2013

    Report

    Report Number
    0009617544-2013-00130
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW RESULTS: VISUAL INSPECTION: THE RETURNED FLEXIBLE SCREWDRIVER WAS FOUND TO BE BROKEN AT TIP. FRACTURE LOOKS TO BE INITIATED FROM THE INNER SIDE OF THE DEVICE AND TENDS TO SPREAD ON THE OUTER DIAMETER. IT IS LIKELY THAT DEVICE YIELDED UNDER BOTH CONSTRAINTS GENERATED BY THE SERVICE LOADING AND INTERNAL STRESSES APPLIED ON A WEAK AREA OF THE DEVICE NEAR THE MILLING AND AT THE JUNCTION OF THE FLEXIBLE SHAFT WITH THE TIP OF INSTRUMENT. FUNCTIONAL INSPECTION: PRODUCT IN ITS AS RECEIVED CONDITION IS OBVIOUSLY NO LONGER FUNCTIONAL. THERE ARE ALTERNATIVE INSTRUMENTS AVAILABLE IN THE SET TO ALLOW THE SURGEON TO COMPLETE THE PROCEDURE SUCCESSFULLY. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: A FLEXIBLE SCREWDRIVER WAS FOUND TO BE BROKEN AT TIP AT RECEIPT. EVENT OCCURRED WHILE DRIVING AN ANCHOR L SCREW. A FORMAL METALLURGICAL STUDY WAS REQUESTED TO AN EXTERNAL LABORATORY WHO PERFORMED STUDY OF THIS RUPTURE: THE BREAKAGE WAS ASSESSED AS BEING THE RESULT OF STRESS CORROSION CRACKING PROCESS THAT WOULD OCCUR UNDER THE INFLUENCE OF BOTH: AN AGGRESSIVE AGENT FOR THE USED MATERIAL AND STRESSES, WHICH MAY BE GENERATED BY THE SERVICE LOADING, AND / OR BE INTERNAL STRESSES. NO ADVERSE CONSEQUENCES WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "SURGEON WAS DRIVING ANCHOR-L SCREW INTO THE ANCHOR-L SPACER WHEN THE TIP OF THE FLEXIBLE SCREW INSERTER BROKE. THE TIP WAS RETRIEVED AND THE SURGEON USED ANOTHER DRIVER TO COMPLETE THE PROCESS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "SURGEON WAS DRIVING ANCHOR-L SCREW INTO THE ANCHOR-L SPACER WHEN THE TIP OF THE FLEXIBLE SCREW INSERTER BROKE. THE TIP WAS RETRIEVED AND THE SURGEON USED ANOTHER DRIVER TO COMPLETE THE PROCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155240 ANCHOR L SCREWDRIVER MODULAR FLEXIBLE INSTRUMENT LXH STRYKER SPINE-FRANCE 12C638

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR