BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 5781678 · Received July 11, 2016

    Report

    Report Number
    0009610622-2016-00324
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 13, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED BOTH NAIL HOLDING SCREWS (NHS) AND BOTH NAIL HANDLES TO BE THE 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. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS. A HARDNESS TEST ACCORDING TO ROCKWELL REVEALED THE HARDNESS OF THE MATERIAL OF ALL ITEMS BEING WITHIN SPECIFIED PARAMETERS. BOTH NHS STUCK WITHIN THE NAIL HANDLES, SO THAT THE NAIL WAS NOT DETACHABLE FROM THE HANDLE WITH CODE #3641. IT WAS NECESSARY TO CUT THE NAIL OFF AND REMOVE THE NHS USING A HAMMER AND A MALLET. AFTER DISASSEMBLING SIGNIFICANT FRETTING MARKS WERE VISIBLE, RUNNING OVER THE WHOLE CIRCUMFERENCE ON THE OUTER SURFACE OF THE NHS SHAFTS, CLOSE TO THE BEGINNING OF THE THREAD. CORRESPONDING FRETTING MARKS WERE ALSO VISIBLE, RUNNING OVER THE WHOLE CIRCUMFERENCE INSIDE THE TUBE OF THE NAIL HANDLES. THE FRETTING CAUSED THE JAMMING OF THE INSTRUMENTS. FRETTING IS A RARE BUT KNOWN REACTION IN CASE THESE MATERIALS COME IN CONTACT WHICH EACH OTHER. DURING SCREWING INTO THE NAIL IT IS POSSIBLE THAT THE NHS GETS IN CONTACT WITH THE INNER SURFACE OF THE NAIL HANDLE TUBE AND FRICTION OCCURS DUE TO A SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION. THE APPEARANCE OF THE DAMAGE INDICATED THAT THE DEVICES GOT JAMMED BY ¿COLD WELDING¿ DUE TO FRICTION CORROSION BEING CAUSED BY HIGH SURFACE PRESSURE. MOST LIKELY HIGH SURFACE PRESSURE GENERATED BY HIGH LOAD APPLIED TO THE NHS HAD LED TO THE FOUND DAMAGES. LOCAL SURFACE PRESSURE MAY ARISE WHEN THE ITEMS ARE ASSEMBLED UNDER MISALIGNMENT (USE ERROR). A PROCESS CHANGE WAS ALREADY PERFORMED IN 2004 TO PREVENT FRETTING REGARDING THE NAIL HOLDING SCREW (SURFACE COATING WAS REMOVED). NO FURTHER ACTIONS WERE INITIATED. THE RETURNED NHS WERE MANUFACTURED POST TO THE CHANGE. THE CHANGE DOES NOT PREVENT A USER ERROR DUE TO OBLIQUE INSERTION. ADDITIONALLY HITTING MARKS WERE FOUND ON BOTH NAIL HANDLE SURFACES. HAMMERING THE NAIL HANDLES IS NOT ALLOWED (ABNORMAL USE). THE HANDLES HAVE THREADED SLOTS TO ASSEMBLE A STRIKE PLATE. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOLDING SCREW T2 TIBIA GOT STUCK IN NAIL ADAPTER TWICE. THE CUSTOMER REPORTED THAT THE SECOND NAIL COULD BE INSERTED FREE-HAND. NO PATIENT HARM WAS DONE. THE STRYKER SALES REP HAS CONFIRMED THAT THERE ARE 2 INSTRUMENTS WITH THE SAME REPORTED ISSUE IN THE ONE OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HOLDING SCREW T2 TIBIA GOT STUCK IN NAIL ADAPTER TWICE. THE CUSTOMER REPORTED THAT THE SECOND NAIL COULD BE INSERTED FREE-HAND. NO PATIENT HARM WAS DONE. THE STRYKER SALES REP HAS CONFIRMED THAT THERE ARE 2 INSTRUMENTS WITH THE SAME REPORTED ISSUE IN THE ONE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437063 NAIL HANDLE T2 TIBIA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KSS148120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other