BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 2830943 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03108
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL NAIL AND FOUR SCREWS ON AN UNKNOWN DATE. THE IMPLANTING FACILITY AND SURGEON IS UNKNOWN. PATIENT PRESENTED TO THE EXPLANT SURGEON COMPLAINING OF IRRITATION AND DISCOMFORT FROM PALPABLE LOCKING SCREWS WHERE PATIENTS WORK BOOT RUBBED. SURGEON RETURNED THE PATIENT TO THE OR ON (B)(6) 2012 FOR REMOVAL OF SCREWS. AT THE PATIENT'S REQUEST, THE SURGEON ALSO REMOVED THE TIBIAL NAIL. SURGEON CONFIRMED THAT HEALING OF ORIGINAL FRACTURE WAS COMPLETE. THE HANDLE OF THE HAMMER SPLIT IN TWO PIECES AND BROKE OFF AS THE SURGEON WAS REMOVING THE NAIL. THERE WERE NO FRAGMENTS TO RETRIEVE FROM THE SURGERY SITE. PATIENT WAS REPORTEDLY RECOVERING WELL. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCREWS