BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245

    MDR report key: 17859019 · Received October 3, 2023

    Report

    Report Number
    9680825-2023-00046
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 21, 2023
    Report Date
    January 5, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K163368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 2023 ORTHOFIX SRL ACQUIRED FROM WITTENSTEIN INTENS GMBH, THE FITBONE¿ SYSTEM, FOR INTRAMEDULLARY LENGTHENING OF THE FEMUR AND TIBIA. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR FITBONE DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY WITTENSTEIN INTENS GMBH. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH. 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. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION: ON FEBRUARY 2023 ORTHOFIX SRL ACQUIRED FROM WITTENSTEIN INTENS GMBH, THE FITBONE¿ SYSTEM, FOR INTRAMEDULLARY LENGTHENING OF THE FEMUR AND TIBIA. THEREFORE, ORTHOFIX IS NOW MANAGING POST-MARKET SURVEILLANCE FOR FITBONE DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY WITTENSTEIN INTENS GMBH. THE NAIL, CODE 60001404, INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH. THE RETURNED NAIL, RECEIVED ON OCTOBER 13, 2023, WAS EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK OF THE NAIL EVIDENCED AS FOLLOWS: - BREAKAGE IN CORRESPONDENCE TO THE ENGINE HOUSING/GUIDE HOUSING WELDING, WITH A BENDING MODE. THE FRACTURE OCCURRED ALONG THE MIDDLE OF THE BEAD. INTERNALLY THE FRACTURE PLANE BENDS AND INTERESTS THE BASE MATERIAL OUTSIDE OF THE WELD AREA, TOWARD THE INNER CHAMFER. THIS WAS CONFIRMED BY OPTICAL MICROSCOPE OBSERVATION, PERFORMED BY AN EXTERNAL LABORATORY; - THE DISTAL PART OF THE NAIL EVIDENCED PRESENCE OF SCRATCHES ON THE GUIDE HOUSING AND ALONG THE TELESCOPIC TUBE; - PRESENCE OF COMPRESSION AREA IN THE FRACTURE SURFACE; - THE PROXIMAL PART OF THE NAIL SHOWN THE GEARBOX SHAFT DEFORMED AND BENT, PROBABLY AS A RESULT OF THE FINAL COLLAPSE; - PRESENCE OF TENSILE AREA IN THE FRACTURE SURFACE; - PRESENCE OF DRILLING SIGNS IN THE PROXIMAL HOLES OF THE RETURNED NAIL; - THE BIPOLAR CONNECTOR WAS COMPLETELY STRIPPED OFF; - THE NAIL LOOKED PARTIALLY DISTRACTED (45MM DISTRACTION OF A TOTAL OF 80 MM). THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. FUNCTIONAL CHECK PERFORMED ON THE MOTORGEAR-BOX TERMINALS CONFIRMED THAT THE DEVICE IS NOT FUNCTIONING ANYMORE, BECAUSE OF THE MECHANICAL DAMAGE OF GEARBOX SHAFT AND/OR OTHER POSSIBLE DAMAGES ON THE MECHANICS OF THE MOTOR. CONCLUSIONS THE ANALYSIS PERFORMED ON THE RETURNED NAIL CONFIRMED THE NOTIFIED ISSUE. THE NAIL IS BROKEN IN CORRESPONDENCE TO ENGINE HOUSING/GUIDE HOUSING WELD, WITH A BENDING MODE AND A FATIGUE-DRIVEN FAILURE PHENOMENON. FAILURE AREA IS CONSISTENT WITH THE MOST CRITICAL LOCATION, IN TERMS OF STRESS CONCENTRATION DUE TO APPLICATION OF A BENDING MOMENT. IT WAS CONFIRMED THAT THE BREAKAGE OF THE NAIL OCCURRED DURING THE BONE CONSOLIDATION PHASE IN AN OVERWEIGHTED PATIENT. ORTHOFIX WOULD LIKE TO REMIND THAT THE INSTRUCTION FOR USE CONTRAINDICATES THE USE OF A FITBONE TAA11/13 FOR PATIENTS WITH A BODY WEIGHT OF > 100 KG (PLEASE REFER TO PQ FBC). BASED ON THE INFORMATION MADE AVAILABLE, IT IS NOT POSSIBLE TO DEFINE THE ROOT CAUSE OF THE PROBLEM OCCURRED, WHICH REMAINS UNKNOWN. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: DR (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: LENGTHENING. - PATIENT INFORMATION: 24 YEARS, FEMALE. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "THE PATIENT WAS OVERWEIGHT, AND HAD RECEIVED A PRECISE NAIL IN PARIS 2 YEARS AGO, WHEN THE NAIL HAD ALREADY BROKEN. WE PLACED THE NAIL 1 YEAR AGO AT THE STRASBOURG HOSPITAL. THE 80 MM LENGTHENING WENT WELL AND CONSOLIDATION IS UNDERWAY. NOW, ALMOST 1 YEAR LATER, THE NAIL HAS BROKEN IN THE 12MM SECTION WITHOUT ANY SHOCK OR ACCIDENT. " THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS). - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - AN ADDITIONAL SURGERY WAS REQUIRED: PERFORMED ON (B)(6) 2023, IMPLANTED A NAIL T2 STRYKER, 4 HOURS INTERVENTION (EMERGENCY REMOVAL AND PLACEMENT OF A TRAUMA NAIL AND LARGE SCARS). - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. - COPY OF THE X-RAY IMAGES IS AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. ORTHOFIX SRL REF: 2023192. DISTRIBUTOR REF: 189.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL. - SURGEON'S NAME: DR (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023 - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: LENGTHENING. - PATIENT INFORMATION: 24 YEARS, FEMALE. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "THE PATIENT WAS OVERWEIGHT, AND HAD RECEIVED A PRECISE NAIL IN PARIS 2 YEARS AGO, WHEN THE NAIL HAD ALREADY BROKEN. WE PLACED THE NAIL 1 YEAR AGO AT THE (B)(6) HOSPITAL. THE 80 MM LENGTHENING WENT WELL AND CONSOLIDATION IS UNDERWAY. NOW, ALMOST 1 YEAR LATER, THE NAIL HAS BROKEN IN THE 12MM SECTION WITHOUT ANY SHOCK OR ACCIDENT. " THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS) .- THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - AN ADDITIONAL SURGERY WAS REQUIRED: PERFORMED ON (B)(6) 2023, IMPLANTED A NAIL T2 STRYKER, 4 HOURS INTERVENTION (EMERGENCY REMOVAL AND PLACEMENT OF A TRAUMA NAIL AND LARGE SCARS). - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE .- COPY OF THE X-RAY IMAGES IS AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR: - THE PATIENT IS DOING WELL, SHE WEIGHS ABOUT 110KG FOR 1,60 M. - THE ENTIRE DEVICE HAS BEEN REMOVED FROM THE PATIENT. ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416890 FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245 FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245 HSB ORTHOFIX SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention