BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø10 XS 125° L170 TAN

    MDR report key: 2960270 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00458
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    May 31, 2012
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PFNA II FOR A TROCHANTERIC FRACTURE ON AN UNKNOWN DATE. IN (B)(6) 2012 PATIENT RETURNED TO HOSPITAL COMPLAINING OF PAIN. THE PATIENT HAD A GAP AT FRACTURED BONY PART, AND THEN HAD A FOLLOW UP. WITH ENDURING A PAIN THE PATIENT STARTED TO TAKE A STROLL AROUND 5,000 PACES PER DAY. THE PAIN GOT GRADUALLY WORSE, AND THEN THE NAIL BREAKAGE WAS FOUND BY THE DOCTOR. THE DOCTORS NOTED THE PATIENT HAD A GAP AT THE FRACTURED BONY PART DUE TO THE NONUNION, AND ACTIVITY OF THE PATIENT IS HIGH. SO CONCENTRATION OF STRESS TO THE BLADE HOLE MADE A METAL FATIGUE AND BREAKAGE. THE TYPING SCORE OF FRACTURE IS CLOSE TO A3. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65038 PFNA-II Ø10 XS 125° L170 TAN PFNA-II KTT SYNTHES GMBH 7789799

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention