BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

    MDR report key: 3223523 · Received July 12, 2013

    Report

    Report Number
    0009610622-2013-00382
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED THE NAIL HANDLE AND NHS TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR A MINIMUM OF APPROX. 2 YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. FRETTING MARKS ARE A RARE BUT KNOWN REACTION. DURING SCREWING 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 MOST LIKELY COLD WELDING WAS OCCURRED IN THE ACTUAL CASE 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 WITHOUT THE SURFACE COATING. 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. NO NON-CONFORMITY IDENTIFIED; ACTIONS ARE IN PLACE.

    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

    IT WAS REPORTED THAT THE NAIL BOLT (SCREW) JAMMED IN NAIL ADAPTER SO NAIL COULD NOT BE ASSEMBLED TO THE TARGETING ARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL BOLT (SCREW) JAMMED IN NAIL ADAPTER SO NAIL COULD NOT BE ASSEMBLED TO THE TARGETING ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321801 NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K622821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other