BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI ELASTIC NAIL 440MM

    MDR report key: 2974366 · Received February 22, 2013

    Report

    Report Number
    2520274-2013-01105
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTY
    PMA / PMN Number
    K971783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE DESIGN HISTORY FILE AND RISK ANALYSIS SHOWED THERE IS A FREQUENCY OF LESS THAN (B)(4) OF THIS REPORTED EVENT. FACTORS THAT MAY CONTRIBUTE TO NON-UNIONS INCLUDE IMPLANT SELECTION FOR SIZE AND TYPE OR PATIENT NON-COMPLIANCE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE REPORTED AS APPROXIMATELY (B)(6) 2012 WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE PRODUCT INVESTIGATION IS CURRENTLY IN THE EVALUATION PROCESS. A MANUFACTURING EVALUATION REVEALED THE FOLLOWING: BECAUSE OF THE DAMAGE TO THE PART, NO ACCURATE MEASUREMENT CAN BE MADE OTHER THAN THE DIAMETER AND THE RAW MATERIAL. THIS COMPLAINT IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    IN (B)(6) 2012, A PATIENT WAS IMPLANTED WITH TWO TI ELASTIC NAILS FOR A LEFT FEMUR FRACTURE. IN (B)(6) 2012, THE PATIENT PRESENTED TO A DIFFERENT SURGEON IN ANOTHER FACILITY COMPLAINING OF PAIN AND A BOWED FEMUR. EXAMINATIONS AND X-RAYS SHOWED A LOSS OF REDUCTION, NON-UNION OF THE FEMUR, AND BENDING OF THE ELASTIC NAILS. IN (B)(6) 2012, RESTRICTIONS WHERE PRESCRIBED FOR USE OF CRUTCHES AND NON-BEARING WEIGHT. ON (B)(6) 2013, THE PATIENT RETURNED TO THE OPERATING ROOM AND THE ELASTIC NAILS WERE REMOVED AND REPLACED WITH ANTEGRADE LATERAL FEMORAL NAILS. THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78903 3.0MM TI ELASTIC NAIL 440MM PIN, FIXATION, SMOOTH HTY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention