BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TL PLUS WIRE TENSIONER WITH TIP

    MDR report key: 20415688 · Received October 10, 2024

    Report

    Report Number
    9680825-2024-00057
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 21, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 54-1139 LOT B4462620 (LOT LASER MARKED ON COMPONENT 2319756-05 AND 2319756-10), BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2024, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FOR THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICES WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK ON BOTH TENSIONERS EVIDENCED SIGNS OF USE, LIKE RUST, SCRATCHES ON THE SURFACE AND HALOS (PROBABLY DUE TO THE CLEANING PROCESS). REFERENCE CODE AND LOT NUMBER ARE STILL VISIBLE. NO OTHER ISSUES WERE DETECTED. THE FUNCTIONAL CHECK ON BOTH TENSIONERS EVIDENCED THAT THE CLOSING MOVEMENT OF THE HANDLES IS NOT FLUID. THE HANDLES COULD NOT BE CLOSED BY HAND. THE FUNCTIONAL TEST OF THE TENSIONERS WAS THEN PERFORMED USING THE CALIBRATED GAUGE CODE SC3065. THE DEVICES COULD NOT TENSION THE WIRE UP TO THE TARGET AS PER ORTHOFIX SPECIFICATIONS. THE DEVICES WERE THEN CLEANED AND LUBRICATED AND RETESTED. THE DEVICES PASSED THE TEST. THE MOVING PARTS ARE FLUID AND BOTH HANDLES CAN BE FULLY CLOSED. FINAL COMMENTS THE RESULTS OF THE TECHNICAL INVESTIGATION CONCLUDED THAT THE RETURNED TENSIONERS STILL PERFORM PROPERLY AFTER THE CLEANING AND LUBRICATION ACTIVITY PERFORMED BY ORTHOFIX SRL. THE FAILURE OCCURRED IS ATTRIBUTABLE TO AN INADEQUATE REPROCESSING OF THE DEVICES AFTER EACH USE (ABSENCE OF LUBRICATION AND/OR DEBRIS NOT REMOVED DURING THE CLEANING ACTIVITIES). ORTHOFIX WOULD LIKE TO REMIND TO FOLLOW THE REPROCESSING AND LUBRICATING INSTRUCTIONS PROVIDED IN THE INSTRUCTIONS FOR USE LEAFLET, REF: PQ WTN. PLEASE BE INFORMED THAT ADEQUATE LUBRICATION SHOULD BE PERFORMED AFTER THE DISINFECTION PROCESS, WHEN THE INSTRUMENT IS COLD. AFTER LUBRICATION, THE DEVICE SHOULD BE OPENED AND CLOSED TO DISTRIBUTE THE LUBRICANT INSIDE THE MECHANISM. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2024-00058 FOLLOW UP 1.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RECEIVED BY ORTHOFIX SRL YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. AS SOON AS FURTHER INFORMATION IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2024-00058.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) SURGEON'S NAME: DR. (B)(6) DATE OF INITIAL SURGERY: ON (B)(6) 2024 BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA SURGERY DESCRIPTION: PILON FX -EX FIX APPLICATION SURGERY DESCRIPTION: FRACTURE TREATMENT PATIENT INFORMATION: 49-YEAR-OLD, FEMALE PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: NEITHER WIRE TENSIONERS IN INSTRUMENT SET TENSIONED WIRES. THEY WERE NEW TENSIONERS, BUT THEY WERE IMPOSSIBLE TO SQUEEZE. WIRES WILL NEED TO BE REPLACED AND PROPERLY TENSIONED IN AN ADDITIONAL SURGERY. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS NOT AVAILABLE TO COMPLETE SURGERY: WIRES WERE LEFT LOOSE THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 40 MINUTES AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT RECEIVED) THE DEVICE WAS NOT AT ITS FIRST USE PATIENT CURRENT HEALTH CONDITION: OVERALL IN GOOD HEALTH, WILL JUST NEED ADDITIONAL SURGERY. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2024-00058 FOLLOW UP 1 MANUFACTURER REFERENCE NUMBER: 2024208 DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. - SURGERY DESCRIPTION: PILON FX -EX FIX APPLICATION. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 49-YEAR-OLD, FEMALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: NEITHER WIRE TENSIONERS IN INSTRUMENT SET TENSIONED WIRES. THEY WERE NEW TENSIONERS, BUT THEY WERE IMPOSSIBLE TO SQUEEZE. WIRES WILL NEED TO BE REPLACED AND PROPERLY TENSIONED IN AN ADDITIONAL SURGERY. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF FRACTURE REDUCTION. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE WAS NOT AVAILABLE TO COMPLETE SURGERY: WIRES WERE LEFT LOOSE. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 40 MINUTES. - AN ADDITIONAL SURGERY IS REQUIRED: TO BE DEFINED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT RECEIVED). - THE DEVICE WAS NOT AT ITS FIRST USE. - PATIENT CURRENT HEALTH CONDITION: OVERALL IN GOOD HEALTH, WILL JUST NEED ADDITIONAL SURGERY. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2024-00058. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946209 TL PLUS WIRE TENSIONER WITH TIP TL PLUS WIRE TENSIONER WITH TIP LXT ORTHOFIX SRL 2319756-05

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female