BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 9468664 · Received December 13, 2019

    Report

    Report Number
    3034525-2019-00189
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 29, 2019
    Report Date
    December 2, 2019
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE NON-UNION IS UNDETERMINED. THERE IS NO WAY TO PREDICT A NON-UNION OR FAILURE TO HEAL. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THIS FAILURE DOES NOT INDICATE A DEFECT IN THE PRODUCT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(4) 2019 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS REPLACED DUE TO A NON-UNION. THE IM NAIL WAS REPLACED WITH A 10MM X 360MM FIN NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "HARVESTED THE REAMINGS FROM THE T-HANDLED REAMERS AND SLID THEM INTO THE SHAFT USING THE PLASTIC TISSUE PROTECTER AS A GUIDE INTO THE TROCHANTERIC HOLE, THEN PASSED THE NAIL. SHE IS BEING DISCHARGED HOME, THE SECOND DAY AFTER SURGERY, WALKING UNASSISTED, ALBEIT WITH A LIMP (SHE ALSO HAD A LIMP PRE-OP, ALTHOUGH SHE COULD SQUAT N' SMILE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263877 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R