BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 4142502 · Received October 6, 2014

    Report

    Report Number
    0009610622-2014-00547
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE NAIL HOLDING SCREW AND THE NAIL HANDLE TO BE THE SUBJECT PRODUCTS. A REVIEW OF THE MANUFACTURING / INSPECTION RECORDS REVEALED NO DISCREPANCIES. THE DEVICES WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2001 AND 2014) WE PRE-SUPPOSE THAT THE DEVICES HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED WITHOUT ANY PROBLEMS. EVALUATION DID NOT REVEAL ANY DISCREPANCIES IN MATERIAL OR MANUFACTURING. SIGNIFICANT FRETTING MARKS RUNNING OVER THE WHOLE CIRCUMFERENCE WERE VISIBLE ON THE OUTER SURFACE OF THE SHAFT OF THE NAIL HOLDING SCREW CLOSE TO THE BEGINNING OF THE THREAD. CORRESPONDING FRETTING MARKS WERE ALSO FOUND INSIDE THE TUBE OF THE NAIL HANDLE. FRETTING MARKS ARE A RARE BUT KNOWN REACTION IF THESE MATERIALS COME IN CONTACT WHICH EACH OTHER. DURING SCREWING THE NAIL HOLDING SCREW INTO THE NAIL IT IS POSSIBLE THAT THE NHS GETS IN CONTACT WITH THE INNER SURFACE OF THE TUBE OF THE NAIL HANDLE AND FRICTION OCCURS DUE TO A SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION (USER RELATED). IN COMBINATION WITH SMALL TOLERANCES IT IS POSSIBLE THAT COLD WELDING OCCURS. THE FOUND FRETTING MARKS ON THE INSTRUMENTS RETURNED INDICATE THAT MOST LIKELY COLD WELDING HAD OCCURRED IN THIS ACTUAL CASE DUE TO REPEATED SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION. 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 WAS MANUFACTURED PRIOR TO THE CHANGE. ANYWAY, THE CHANGE DOES NOT PREVENT A USER ERROR DUE TO OBLIQUE INSERTION. THE CASE IS ATTRIBUTED TO AN INADEQUATE HANDLING BY THE USER. 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 THIRD PARTY DISTRIBUTOR, HAS REPORTED THAT THE THREADS ON THE NAIL HOLDING SCREW REF (B)(4) ARE ALLEGEDLY DAMAGED AND IT CAN SEEN THAT THERE IS A SCRAPE ON THE INSIDE OF METAL PART OF THE TIBIAL TARGET DEVICE REF (B)(4) AND THIS IS PREVENTING THE NAIL HOLDING SCREW FROM LOCKING ONTO THE NAIL.

    Description of Event or Problem · 1

    THE THIRD PARTY DISTRIBUTOR, HAS REPORTED THAT THE THREADS ON THE NAIL HOLDING SCREW REF (B)(4) ARE ALLEGEDLY DAMAGED AND IT CAN SEEN THAT THERE IS A SCRAPE ON THE INSIDE OF METAL PART OF THE TIBIAL TARGET DEVICE REF (B)(4) AND THIS IS PREVENTING THE NAIL HOLDING SCREW FROM LOCKING ONTO THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624689 NAIL HANDLE T2 TIBIA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KHI133056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other