BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA DEFORMITY 5MM BLOCKER INSERTER

    MDR report key: 3953948 · Received July 23, 2014

    Report

    Report Number
    0009617544-2014-00318
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: VISUAL INSPECTION CONFIRMED THAT THE TIP HAD FRACTURED OFF OF THE MAIN BODY. HOWEVER, THIS TIP WAS NOT RETURNED BACK, SO TESTING COULD NOT BE PERFORMED ON IT. REVIEW OF THE CORRESPONDENCE CONFIRMS THAT THE EVENT OCCURRED DURING PROVISIONAL TIGHTENING OF THE BLOCKER. IN DEFORMITY CASES THE RODS ARE OFTEN NOT SEATED PROPERLY WITHIN THE SCREW TULIP, WHICH MAY REQUIRE THAT A LARGE AMOUNT OF FORCE BE APPLIED ON THE ROD TO SEAT IT PROPERLY. THE SURGICAL TECHNIQUE ADVISES THE USER TO PERSUADE THE ROD AND THEN PROVISIONALLY LOCK, SO THAT THE INSERTER DOES NOT BECOME THE SOLE SOURCE OF FORCE PERSUADING THE ROD INTO PLACE. NO MANUFACTURING OR MATERIAL ISSUES WERE IDENTIFIED DURING INVESTIGATION. CONCLUSION: THE MOST LIKELY CAUSE OF THE BLOCKER INSERTER FRACTURE IS EXCESSIVE TORQUE APPLIED TO THE INSERTER DURING TIGHTENING OF THE BLOCKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BLOCKER TIGHTENING, XIA DEFORMITY 5MM BLOCKER INSERTER WAS BROKEN. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED WITH THE SPARE BLOCKER INSERTER IN THE KIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BLOCKER TIGHTENING, XIA DEFORMITY 5MM BLOCKER INSERTER WAS BROKEN. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED WITH THE SPARE BLOCKER INSERTER IN THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431684 XIA DEFORMITY 5MM BLOCKER INSERTER INSTRUMENT-INSERTER LXH STRYKER SPINE-FRANCE 128070

    Patients

    Seq Age Sex Outcome Treatment
    1