BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS CROSS CONNECTOR PLUG DRIVER

    MDR report key: 3019439 · Received March 25, 2013

    Report

    Report Number
    0009617544-2013-00095
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY, AND RISK ASSESSMENT. RESULTS: VISUAL INSPECTION: PRODUCT WERE VISUALLY INSPECTED UPON RETURN AND CONFIRMED TO BE DAMAGED. DEVICE HISTORY REVIEW: MANUFACTURING FILES WERE REVIEWED. NO NONCONFORMITIES OR DEVIATIONS LINKED TO THE REPORTED EVENT WERE FOUND DURING MANUFACTURING. COMPLAINT HISTORY: ONLY ONE SIMILAR COMPLAINT WAS FOUND IN COMPLAINT MANAGEMENT DATABASES DATING BACK TO MARCH 2004. IN THAT INVESTIGATION, IT WAS CONCLUDED THAT CANTILEVER FORCES ON THE DEVICE DURING UNLOCKING OF THE CONNECTOR WERE RESPONSIBLE FOR THE DAMAGE. CONCLUSION: THERE IS NO HIGHLIGHTED ADVERSE TREND FOR SUCH EVENT UPON REVIEW OF PREVIOUS COMPLAINTS. ONE OF THE RETURNED DEVICES WAS CONFIRMED TO BE BROKEN AT THE EXTREME TORX TIP. THE DAMAGE PATTERN IS SIMILAR TO THE ONE HIGHLIGHTED UNDER PER 213 116 ON WHICH SEM ANALYSIS WAS CONDUCTED SUPPORTING A RUPTURE CONSISTENT WITH STATIC DUCTILE FRACTURE UNDER FLEXURAL LOAD. HENCE IT SUPPORTS A BREAKAGE UNDER CANTILEVER. THE OTHER RETURNED DRIVER APPEARED LESS COMPROMISED, ONLY SLIGHT TWISTED, DAMAGED EDGE OF PIN TIP WAS NOTED SUPPORTING THAT THE TORQUE LOADS WERE EXCLUSIVELY SUPPORTED BY THE TIP PIN WHERE THE TORX IS SUPPOSED TO TRANSFER THE TORQUE. ALL THIS SUGGESTS THAT DEVICE MAY HAVE NOT BEEN PROPERLY INSERTED IN PLUG. GIVEN THE TORX IS NOT COMPROMISED, BOTH ITEMS WERE FOUND STILL ABLE TO PERFORM THE LOCKING OF THE CONNECTOR PLUG. IN THIS CASE, NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED TO DATE FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "DURING RADIUS SURGERY, THE SURGEON USED THE CROSS CONNECTOR. WHEN THE SURGEON USED CROSS CONNECTOR PLUG DRIVER AND TIGHTENED LOCKING PLUG, THE TIP OF DRIVER BROKE. ALTHOUGH THE SURGEON USED ONE MORE DRIVER, THE TIP OF DRIVER BROKE. THEREFORE, ONLY ONE SIDE LOCKED CROSS CONNECTOR AND THE SURGEON COMPLETED THE OPERATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "DURING RADIUS SURGERY, THE SURGEON USED THE CROSS CONNECTOR. WHEN THE SURGEON USED CROSS CONNECTOR PLUG DRIVER AND TIGHTENED LOCKING PLUG, THE TIP OF DRIVER BROKE. ALTHOUGH THE SURGEON USED ONE MORE DRIVER, THE TIP OF DRIVER BROKE. THEREFORE, ONLY ONE SIDE LOCKED CROSS CONNECTOR AND THE SURGEON COMPLETED THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122315 RADIUS CROSS CONNECTOR PLUG DRIVER INSTRUMENT LXH STRYKER SPINE-FRANCE 086193

    Patients

    Seq Age Sex Outcome Treatment
    1