BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX

    MDR report key: 2971062 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-00382
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 5400957 REVEALED THAT THE EXTENSION END CAP FOR FEMORAL NAILS, PART NUMBER 04.003.006S, WAS MANUFACTURED BY MARK TWO ENGINEERING. PO 725796 FOR 25 PARTS WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE IS DATED 2/14/2007. 25 PARTS WERE RELEASED TO THE WAREHOUSE ON 4/11/2007. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL NAIL ON (B)(6) 2012. IT WAS DISCOVERED ON AN UNKNOWN DATE THE PATIENT HAD A NONUNION. PATIENT RETURNED TO OR ON (B)(6) 2013 FOR REMOVAL OF IM NAIL, NAIL EXCHANGE, AND BONE GRAFT DUE TO NON-UNION. THIS IS 2 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76896 16MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX END CAP T40 STARDRIVE HSB SYNTHES MONUMENT 5400957

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention