BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITBONE TAA0940-T-200 INTRAMEDULLARY LENGTHENING NAIL

    MDR report key: 17170063 · Received June 21, 2023

    Report

    Report Number
    9680825-2023-00025
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    April 28, 2023
    Report Date
    August 2, 2023
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K203399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    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 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. A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT TO OUR MEDICAL CONSULTANT. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. "I NOTE IN THE REPORT THAT THE ONLY COMMENT ABOUT THE "ISSUES" IS THAT THE CABLE SEEMED TO MAKE DIFFICULTIES AND THE THREAD IN THE NAIL COULD NOT BE ENGAGED. THE DELAY WAS STATED TO BE ONE HOUR. IN THE AP VIEW OF THE X-RAY IMAGES THE CONNECTION BOLT IS ANGLED MEDIALLY AND THE TIP IS RESTING ON THE MEDIAL EDGE OF THE FITBONE, A LONG WAY FROM THE CENTRE. IN THE LATERAL VIEW THE CONNECTION BOLT TIP LOOKS MORE CENTRAL, BUT THE INSTRUMENT IS NOT ALIGNED WITH THE PROXIMAL PART OF THE FITBONE, AND NEEDS TO BE LIFTED AWAY FROM THE FEMUR TO BECOME ALIGNED. IN OTHER WORDS, THEY WERE NEVER GOING TO GET THE BOLT CONNECTED IN THIS MISALIGNED POSITION". CONCLUSIONS A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE MEDICAL EVALUATION INDICATES AS FOLLOWS: "I NOTE IN THE REPORT THAT THE ONLY COMMENT ABOUT THE "ISSUES" IS THAT THE CABLE SEEMED TO MAKE DIFFICULTIES AND THE THREAD IN THE NAIL COULD NOT BE ENGAGED. THE DELAY WAS STATED TO BE ONE HOUR. IN THE AP VIEW OF THE X-RAY IMAGES THE CONNECTION BOLT IS ANGLED MEDIALLY AND THE TIP IS RESTING ON THE MEDIAL EDGE OF THE FITBONE, A LONG WAY FROM THE CENTRE. IN THE LATERAL VIEW THE CONNECTION BOLT TIP LOOKS MORE CENTRAL, BUT THE INSTRUMENT IS NOT ALIGNED WITH THE PROXIMAL PART OF THE FITBONE, AND NEEDS TO BE LIFTED AWAY FROM THE FEMUR TO BECOME ALIGNED. IN OTHER WORDS, THEY WERE NEVER GOING TO GET THE BOLT CONNECTED IN THIS MISALIGNED POSITION". CONSIDERING THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW ANY CONCLUSION WITH REGARDS TO THE COMPLAINED DIFFICULTY OF THE FITBONE REMOVAL PROCESS. ORTHOFIX WOULD LIKE TO REMIND THAT THE INSTRUCTIONS TO REMOVE A FITBONE TIBIA NAIL ARE LISTED IN THE OPERATIVE TECHNIQUE, RE. FB-2022-OPT. IN CASE FURTHER INFORMATION OR THE DEVICE CONCERNED ARE PROVIDED, ORTHOFIX WILL RE-OPEN THE INVESTIGATION ON THE CASE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 2023 ORTHOFIX SRL ACQUIRED FROM (B)(6) 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 (B)(6) GMBH. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY (B)(6) GMBH. A TECHNICAL EVALUATION OF THE DEVICE CONCERNED IS NOT POSSIBLE AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. ORTHOFIX IS CURRENTLY PERFORMING THE EVENT INVESTIGATION WITH THE INFORMATION MADE AVAILABLE UP TO NOW. AS SOON AS 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.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2023 - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA - SURGERY DESCRIPTION: LENGTHENING - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "DIFFICULTIES WITH THE CABLE. IT IS BINDING WITH A RISK OF CUTTING IT. NAIL THREAD TOO FAR FROM EDGE". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (1 HOUR DELAY) - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN - PATIENT'S CURRENT HEALTH CONDITION: "THE PATIENT GOES WELL." ON JUNE 14, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: - THE DEVICE IS NOT RETURNING (DISCARDED BY THE HOSPITAL) - THE PROBLEM OCCURRED ON SCHEDULED DEVICE REMOVAL, PERFORMED ON (B)(6) 2023 - THE FITBONE NAIL WAS IMPLANTED ON (B)(6) 2022 - COPIES OF THE X-RAY IMAGES. ON JUNE 16, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: - THE COMPLAINT FROM THE SURGEON CONCERNS THE REMOVAL PROCESS, NOT DIRECTLY THE PRODUCT. THE SURGEON DID NOT OBSERVE ANY FAULT ON THE PRODUCT ITSELF. FOR THIS REASON THE HOSPITAL DISCARDED THE PRODUCTS. ON JUNE 21, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: - THE TOTAL TIME DURATION OF THE SURGERY WAS 2 HOURS. - (B)(6) IS A SPECIALIST. ORTHOFIX SRL REF: (B)(4). LOCAL DISTRIBUTOR REF: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY 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: TIBIA. SURGERY DESCRIPTION: LENGTHENING. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "DIFFICULTIES WITH THE CABLE. IT IS BINDING WITH A RISK OF CUTTING IT. NAIL THREAD TOO FAR FROM EDGE". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE (1 HOUR DELAY). AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT'S CURRENT HEALTH CONDITION: "THE PATIENT GOES WELL." ON JUNE 14, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: THE DEVICE IS NOT RETURNING (DISCARDED BY THE HOSPITAL). THE PROBLEM OCCURRED ON SCHEDULED DEVICE REMOVAL, PERFORMED ON (B)(6) 2023. THE FITBONE NAIL WAS IMPLANTED ON (B)(6) 2022. COPIES OF THE X-RAY IMAGES. ON JUNE 16, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: THE COMPLAINT FROM THE SURGEON CONCERNS THE REMOVAL PROCESS, NOT DIRECTLY THE PRODUCT. THE SURGEON DID NOT OBSERVE ANY FAULT ON THE PRODUCT ITSELF. FOR THIS REASON THE HOSPITAL DISCARDED THE PRODUCTS. ON JUNE 21, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL DETAILS: THE TOTAL TIME DURATION OF THE SURGERY WAS 2 HOURS. DR (B)(6) IS A SPECIALIST. ORTHOFIX SRL REF: (B)(4). LOCAL DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247991 FITBONE TAA0940-T-200 INTRAMEDULLARY LENGTHENING NAIL FITBONE TAA0940-T-200 INTRAMEDULLARY LENGTHENING NAIL HSB ORTHOFIX SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown