BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T40 STARDRIVE 0MM EXT FOR FEMORAL NAILS-EX

    MDR report key: 2890987 · Received December 31, 2012

    Report

    Report Number
    1719045-2012-01502
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # 6596019 REVEALED THAT PART NUMBER 04.001.000 WAS ASSOCIATED WITH THIS LOT NUMBER NOT 04.003.000. THE LOT WAS MANUFACTURED BY MARK TWO ENGINEERING. PO # 1242132, FOR 247 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) REVISION "F" ON 3/31/2011. THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HUMERAL NAIL AND SCREW CONSTRUCT ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2011. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE DUE TO NON UNION. PATIENT WAS REVISED TO ORIF WITH LCP LARGE FRAG PLATE AND SCREW CONSTRUCT. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI END CAP T40 STARDRIVE 0MM EXT FOR FEMORAL NAILS-EX END CAP KTT SYNTHES MONUMENT 6596019

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention NAIL, SCREWS