BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE PROXIMAL FEMUR NAIL

    MDR report key: 10028610 · Received May 6, 2020

    Report

    Report Number
    9615128-2020-00005
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    March 19, 2020
    Report Date
    June 5, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109336534
    PMA / PMN Number
    K153536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED ITEM WAS RECEIVED AND UNDERWENT AN EXAMINATION BY THE COMPANY. EXAMINATION OF THE NAIL, INCLUDING MICROSCOPIC VISUAL INSPECTION, INDICATED IT HAD A FATIGUE FRACTURE. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE INDICATED THE IMPLANT WAS MANUFACTURED ACCORDING TO SPECIFICATION. BREAKAGE OF PROXIMAL FEMUR NAILS IS KNOWN AND DOCUMENTED IN THE LITERATURE, WITH REPORTED RATES THAT RANGE FROM 0.2% TO 5.6%(1). THE RISK OF IMPLANT FATIGUE FAILURE INCREASES IN THE CASE OF PATHOLOGICAL FRACTURES, LIKE IN THE REPORTED CASE. THE REPORTED CASE INVOLVED A (B)(6) YEAR OLD PATIENT WITH A TUMOR. IMPORTANTLY, NAIL WITHHELD FOR MORE THAN 9 MONTHS WHICH IS CONSIDERED A LONG PERIOD IN CASES WITH COMPROMISED BONE HEALING. (1) JOHNSON NA ET AL., RISK FACTORS FOR INTRAMEDULLARY NAIL BREAKAGE IN PROXIMAL FEMORAL FRACTURES: A 10-YEAR RETROSPECTIVE REVIEW. ANN R COLL SURG ENGL. 2017; 99(2): 145-150.

    Description of Event or Problem · 1

    A PROXIMAL FEMUR NAIL WAS IMPLANTED TO TREAT A PATHOLOGIC FRACTURE (ONCOLOGICAL PATIENT) IN (B)(6). MORE THAN 9 MONTHS POST-OPERATION, NAIL BROKE AT THE SUB-TROCHANTERIC AREA AND WAS REPLACED WITH A METAL NAIL IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491557 PICCOLO COMPOSITE PROXIMAL FEMUR NAIL INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. Proximal Femur Nail PPF01196 07290109336534

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention