BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP T2 TIBIA +5 MM

    MDR report key: 2973005 · Received February 21, 2013

    Report

    Report Number
    0009610622-2013-00058
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 20, 2012
    Report Date
    January 29, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). BOTH IMPLANTS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. AN ASSEMBLING OF THE NAIL AND END CAP WAS POSSIBLE ALTHOUGH BOTH ARE HEAVILY DAMAGED BY TOOLS. NO SIGNS OF FRETTING ARE VISIBLE ON THE CONTACT SURFACES; FURTHERMORE BOTH THREADS WERE FOUND FUNCTIONAL. THE SUPPLIER FOR DECONTAMINATION REPORTED THAT HE HAD NO DIFFICULTIES TO REMOVE THE END CAP OUT OF THE NAIL WITH THE SPECIFIED STRYKER SCREWDRIVER SHAFT. THEREFORE THE REPORTED ISSUE WAS NOT REPRODUCIBLE AND THE ROOT CAUSE COULD NOT BE DETERMINED. MOST LIKELY THE SURGEON TRIED TO REMOVE THE END CAP WITHOUT THE SPECIFIED SCREWDRIVER SHAFT OR THE BONE RESIDUES ON THE INNER NAIL THREAD AND ON THE END CAP THREAD CAUSED A JAMMING OF BOTH IMPLANTS. IF THESE POSSIBILITIES WERE THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED DUE TO MISSING INFORMATION; A MORE PRECISE STATEMENT IS NOT POSSIBLE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    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 BY OUR SALES REP THAT IT WAS IMPOSSIBLE TO EXTRACT THE END CAP. THE END CAP WAS SOLID WITH THE NAIL. THE SURGEON USED AN IMPACTOR TO EXTRACT THE NAIL. THERE WAS A DELAY OF 120 MIN, BUT IT WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR SALES REP THAT IT WAS IMPOSSIBLE TO EXTRACT THE END CAP. THE END CAP WAS SOLID WITH THE NAIL. THE SURGEON USED AN IMPACTOR TO EXTRACT THE NAIL. THERE WAS A DELAY OF 120 MIN, BUT IT WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76450 END CAP T2 TIBIA +5 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other