BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAIL D.1

    MDR report key: 3481216 · Received November 8, 2013

    Report

    Report Number
    9680825-2013-00028
    Event Type
    Injury
    Date Received
    November 8, 2013
    Report Date
    November 4, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 99-T730350 LOT NUMBER V1227144 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2011, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ONGOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION WILL BE AVAILABLE. MANUFACTURER COMMENTS: ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS DATE OF INITIAL SURGERY, DATE OF REVISION SURGERY, COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE PRE AND POST-OPERATIVE XRAYS TO FINALIZE THE MEDICAL EVALUATION AND INFORMATION ON PATIENT CURRENT HEALTH CONDITION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    (B)(4). SURGERY DESCRIPTION: FEMUR FRACTURE TREATMENT, EVENT DESCRIPTION: THE SCREW MISSED THE NAIL; THEREFORE, WHEN THE PATIENT WAS MOBILIZED, THE NAIL MIGRATED THROUGH THE KNEE AND THE FEMUR FRACTURED. THEREFORE, PATIENT HAS TO HAVE REVISION SURGERY. THE COMPLAINT REPORT FROM INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT (LOSS OF FRACTURE REDUCTION). THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE. MANUFACTURER REFERENCE NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578905 CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAIL D.1 FEMORAL CENTRONAIL D.10 MM-L.350 MM HSB ORTHOFIX SRL 99-T730350 V1227144

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention NO INFORMATION HAS BEEN MADE AVAILABLE.