BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR L SCREWDRIVER MODULAR FLEXIBLE

    MDR report key: 3972599 · Received August 1, 2014

    Report

    Report Number
    0009617544-2014-00345
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MAXIMUM TORSIONAL STRENGTH OF SCREWDRIVER WAS DETERMINED TO BE 12 NM DURING DEVICE VERIFICATION TESTING. HOWEVER, THE REMAINING HALF OF THE RETURNED SCREWDRIVER TIP WAS SIGNIFICANTLY BENT INDICATING A CANTILEVER LOAD AS WELL AS TORSION WAS BEING APPLIED AT THE TIME OF FRACTURE. THE IFU FOR ANCHOR L STATES THAT INSTRUMENTS WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXTENSIVE FORCE ARE MORE SUSCEPTIBLE TO FRACTURE DEPENDING ON THE OPERATIVE PRECAUTION, NUMBER OF PROCEDURES, AND DISPOSAL ATTENTION. CONCLUSION: THE PLAUSIBLE ROOT CAUSE IS NORMAL WEAR RESULTING FROM EXTENSIVE USE.

    Description of Event or Problem · 1

    IT¿S REPORTED THAT THE SURGEON WAS USING THE FLEXIBLE SCREWDRIVER SHAFT TO INSERT AN ANCHOR L SCREW THROUGH THE ALL IN ONE GUIDE INTO THE ANCHOR L IMPLANT. AS THE SURGEON WAS INSERTING THE SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE SURGEON USED THE RIGID SCREWDRIVER IN PLACE OF IT. THERE WAS A MINUTE DELAY AND NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 1

    IT¿S REPORTED THAT THE SURGEON WAS USING THE FLEXIBLE SCREWDRIVER SHAFT TO INSERT AN ANCHOR L SCREW THROUGH THE ALL IN ONE GUIDE INTO THE ANCHOR L IMPLANT. AS THE SURGEON WAS INSERTING THE SCREW, THE TIP OF THE SCREWDRIVER BROKE. THE SURGEON USED THE RIGID SCREWDRIVER IN PLACE OF IT. THERE WAS A MINUTE DELAY AND NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450466 ANCHOR L SCREWDRIVER MODULAR FLEXIBLE INSTRUMENT-SCREWDRIVER LXH STRYKER SPINE-FRANCE 137685

    Patients

    Seq Age Sex Outcome Treatment
    1