BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 3948748 · Received July 22, 2014

    Report

    Report Number
    0009610622-2014-00363
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 4, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE EVALUATION REVEALED THE NAIL, NAIL ADAPTER AND NAIL HOLDING SCREW (NHS) TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. REGARDING JAMMING OF THE NAIL AND INSTRUMENTS: THE JAMMING OF BOTH INSTRUMENTS WAS CAUSED BY FRETTING MARKS. THE HEAVILY DAMAGES ON THE NHS HEXAGON HEAD INDICATE THAT THE SURGEON TRIED TO DISASSEMBLE THE NHS AND NAIL ADAPTER WITH STRONG FORCES. FRETTING MARKS ARE A RARE BUT KNOWN REACTION. DURING SCREWING THE NHS INTO THE NAIL IT IS POSSIBLE THAT THE NHS GET CONTACT WITH THE INNER SURFACE OF THE NAIL HANDLE AND FRICTION OCCURS DUE TO A NOT OPTIMAL AXIAL INSERTION (USER RELATED). IN COMBINATION WITH SMALL TOLERANCES IT IS POSSIBLE THAT COLD WELDING OCCURS. THE FOUND FRETTING MARKS INDICATE THAT COLD WELDING OCCURRED, MOST LIKELY DUE TO AN OBLIQUE INSERTION CONTRIBUTED BY STRONG TORSIONAL FORCES. A PROCESS CHANGE WAS ALREADY PERFORMED IN 2004 TO PREVENT FRETTING REGARDING THE NHS (SURFACE COATING WAS REMOVED). NO FURTHER ACTIONS WERE INITIATED. THE RETURNED NHS WAS MANUFACTURED POST TO THE CHANGE. ANYWAY, THE CHANGE DOES NOT PREVENT A USER ERROR DUE TO OBLIQUE INSERTION. THE ISSUE IS ATTRIBUTED TO AN IMPROPER HANDLING BY THE USER. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE THAT DURING A PROCEDURE THEY ATTACHED THE NAIL ADAPTER, THE NAIL HOLDING SCREW AND THE NAIL BUT THE NAIL WAS TURNED TO 180. THIS HAS BEEN NOTICED AFTER THE NAIL WAS IMPLANTED. THE SURGEON TRIED TO ASSEMBLE ALL COMPONENTS TO PLACE THE NAIL IN THE RIGHT POSITION, BUT FAILED. THE COMPONENTS JAMMED. THEREFORE, THE NAIL HAS BEEN IMPLANTED WITHOUT THE TARGETING DEVICE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE THAT DURING A PROCEDURE THEY ATTACHED THE NAIL ADAPTER, THE NAIL HOLDING SCREW AND THE NAIL BUT THE NAIL WAS TURNED TO 180. THIS HAS BEEN NOTICED AFTER THE NAIL WAS IMPLANTED. THE SURGEON TRIED TO ASSEMBLE ALL COMPONENTS TO PLACE THE NAIL IN THE RIGHT POSITION, BUT FAILED. THE COMPONENTS JAMMED. THEREFORE, THE NAIL HAS BEEN IMPLANTED WITHOUT THE TARGETING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428570 NAIL HANDLE T2 TIBIA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KHI133056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other