BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICCOLO COMPOSITE PROXIMAL FEMUR NAIL

    MDR report key: 10383119 · Received August 9, 2020

    Report

    Report Number
    9615128-2020-00009
    Event Type
    Injury
    Date Received
    August 9, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 9, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109336510
    PMA / PMN Number
    K153536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE INVOLVED AN OSTEOPETROSIS PATIENT WITH NONUNION AND IMPLANT FAILURE AFTER THREE MONTHS. EXAMINATION OF INVOLVED NAIL MANUFACTURING RECORDS INDICATED THE IMPLANT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE IMPLANT WAS NOT AVAILABLE TO THE COMPANY; THUS, ITS PHYSICAL EXAMINATION WAS NOT POSSIBLE. X-RAYS PROVIDED (OF POST NAIL FAILURE) INDICATED THE CASE INVOLVED NONUNION OF THE FRACTURE. CASES OF NONUNION AS WELL AS SUBSEQUENT IMPLANT FAILURE ARE KNOWN AND DOCUMENTED IN THE LITERATURE, WITH REPORTED NAIL BREAKAGE RATES THAT RANGE FROM 0.2% TO 5.6% (1). (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 SUB-TROCHANTERIC FRACTURE IN A PATIENT WITH OSTEOPETROSIS. APPROXIMATELY 3 MONTHS AFTER IMPLANTATION, NAIL BROKE AND WAS REMOVED IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847402 PICCOLO COMPOSITE PROXIMAL FEMUR NAIL INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. Proximal Femur Nail PPF01580 07290109336510

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention