BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

    MDR report key: 3902194 · Received June 30, 2014

    Report

    Report Number
    0009610622-2014-00290
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 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

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE EVALUATION REVEALED THE NAIL HANDLE AND THE 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. AS THE DEVICES HAD BEEN IN USE FOR APPROX. 8 YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. THE JAMMING OF BOTH INSTRUMENTS WAS CAUSED BY FRETTING MARKS. FRETTING MARKS ARE KNOWN FROM PREVIOUS COMPLAINTS AND 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 ADAPTER 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 WAS OCCURRED, MOST LIKELY DUE TO AN OBLIQUE INSERTION. 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 CASE IS ATTRIBUTED TO AN IMPROPER HANDLING BY THE USER. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. O NON-CONFORMITY IDENTIFIED; ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE DURING A PROCEDURE THE NAIL HOLDER SCREW JAMMED IN THE TIBIA NAIL. THERE WAS NO CHANCE TO REMOVE THE NAIL. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE DURING A PROCEDURE THE NAIL HOLDER SCREW JAMMED IN THE TIBIA NAIL. THERE WAS NO CHANCE TO REMOVE THE NAIL. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379221 NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K807998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other