BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE

    MDR report key: 2874678 · Received December 15, 2012

    Report

    Report Number
    1719045-2012-01379
    Event Type
    Injury
    Date Received
    December 15, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBER INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE STERILIZATION PARAMETERS ARE CONSISTENT WITH SYNTHES CURRENT IFUS, AND THE SUPPORTING VALIDATIONS DEMONSTRATE THAT A STERILITY ASSURANCE LEVEL, SAL, OF 10, 6 IS ACHIEVABLE WHEN THE IFUS ARE EMPLOYED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL EX NAIL CONSTRUCT ON (B)(6) 2012. ON (B)(6) 2012, PATIENT WAS DIAGNOSED WITH OPERATIVE SITE INFECTION. AT THIS TIME, THE SURGEON WASHED OUT THE OPERATIVE SITE INFECTION AND TREATED WITH ANTIBIOTICS. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE TIBIAL NAIL HSB SYNTHES MONUMENT 5877580

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCREW