BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL,HINGE, UNIVERSAL

    MDR report key: 19556784 · Received June 18, 2024

    Report

    Report Number
    9680825-2024-00037
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    June 6, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1815882 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2022 WAS COMPRISED OF 40 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE DEVICES INVOLVED IN THIS EVENT WERE NOT RECEIVED AT ORTHOFIX YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE 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 NUMBERS 9680825-2024-00035, 9680825-2024-00036, 9680825-2024-00038, 9680825-2024-00039.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1815882 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2022 WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE RETURNED DEVICES WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. ONLY THE SUBCOMPONENT CODE (B)(4) WAS RETURNED FOR THE ANALYSIS, WHILE THE THREADED STUD CODE (B)(4) WAS NOT RETURNED. THE SUBCOMPONENTS RECEIVED WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. 1) IN THE VISUAL CHECK IT WAS EVIDENCED THAT (B)(4) RETURNED ITEMS DO NOT MOVE FREELY. ALL THE RETURNED ITEMS HAVE SLIGHT SIGNS ON THE CENTRAL PART, WHICH DO NOT INFLUENCE THE FUNCTIONALITY OF THE ITEMS. REFERENCE CODE AND LOT NUMBER ARE STILL VISIBLE IN ALL THE FIVE HINGES. 2) THE DIMENSIONAL CHECK PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. 3) IN THE FUNCTIONAL CHECK IT WAS CONFIRMED A HINDERED ROTATION IN (B)(4) HINGES. ON THE FIFTH HINGE, LOT REFERENCE B1815882, BOTH CYLINDERS COULD ROTATE PROPERLY. NO LOCKING OF THE CYLINDERS WAS OBSERVED. THE DEVICE PERFORMS PROPERLY. CONCLUSIONS: THE ANALYSIS PERFORMED EVIDENCED THAT IN (B)(4) HINGES INVOLVED, IT WAS NOT POSSIBLE TO ROTATE AT LEAST ONE OF THE CYLINDERS. THE VISUAL AND DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. PLEASE NOTE THAT THE CHECK OF THE CORRECT FUNCTIONALITY OF THE CYLINDER'S ROTATION, IS PERFORMED ON THE 100% OF THE ITEMS BOTH IN THE MECHANICAL WORKSHOP DURING MANUFACTURING PROCESS, AND ON THE 100% OF THE ITEMS DURING INCOMING INSPECTION AND BEFORE THE RELEASE TO THE MARKET. FROM THE EVIDENCE ABOVE, AND FROM THE INFORMATION COMMUNICATED BY THE USER (THE DEVICES INITIALLY MOVED FREELY, WHILE THEY STARTED TO SEIZE UP DURING OPERATION), IT IS POSSIBLE TO ASSUME THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS AND THAT THE DAMAGE OCCURRED AFTER THE PRODUCT RELEASE ON THE MARKET, POSSIBLY DURING THE SPECIFIC APPLICATION. NEVERTHELESS, SINCE THE COMPLETE LOADING HISTORY DURING FRAME CONSTRUCTION/APPLICATION IS NOT KNOWN, IT IS NOT POSSIBLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE FAILURE OCCURRED. ORTHOFIX SRL HISTORICAL RECORDS SHOW THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED REGARDING THIS SPECIFIC DEVICE CODE AND LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBERS 9680825-2024-00035 FOLLOW UP 1, 9680825-2024-00036 FOLLOW UP 1, 9680825-2024-00038 FOLLOW UP 1, 9680825-2024-00039 FOLLOW UP 1.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA - SURGERY DESCRIPTION: CORRECTION - PATIENT'S INFORMATION: FEMALE; WEIGHT 60 KG; HEIGHT 150 CM - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: UNIVERSAL HINGE PART NO 55-1176. INITIALLY WOULD MOVE FREELY THOUGH RANGE OF MOTION (ROM) BUT AFTER A COUPLE OF CYCLES HINGE SEIZED UP AND BECAME VERY DIFFICULT TO MOBILISE. IT HAPPENED WITH ALL SAME CODE HINGES IN THE SET. ESTABLISHED RODS WERE NOT OVER INSERTED. COULD BE A LUBRICATION ISSUE. PROLONGED SURGERY DUE TO HAVING TO REBUILD CONSTRUCT MID CASE WITH ALTERNATE PARTS. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE - A REPLACEMENT DEVICE OF THE SAME MODEL WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: QUICK STRUTS WERE USED TO COMPLETE SURGERY - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 60 MINUTES - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE - COPY OF X-RAY IMAGES IS NOT AVAILABLE - THE PROBLEM OCCURRED DURING THE FIRST USE OF THE DEVICE - PATIENT'S CURRENT HEALTH CONDITION: PATIENT OUTCOME WAS SUCCESSFUL AT THIS MOMENT. NO ISSUES. MANUFACTURER REF: 2024117 DISTRIBUTOR REF: 834757.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL. - SURGEON'S NAME: MR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. - SURGERY DESCRIPTION: CORRECTION. - PATIENT'S INFORMATION: FEMALE; WEIGHT 60 KG; HEIGHT 150 CM. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: UNIVERSAL HINGE PART NO 55-1176. INITIALLY WOULD MOVE FREELY THOUGH RANGE OF MOTION (ROM) BUT AFTER A COUPLE OF CYCLES HINGE SEIZED UP AND BECAME VERY DIFFICULT TO MOBILISE. IT HAPPENED WITH ALL SAME CODE HINGES IN THE SET. ESTABLISHED RODS WERE NOT OVER INSERTED. COULD BE A LUBRICATION ISSUE. PROLONGED SURGERY DUE TO HAVING TO REBUILD CONSTRUCT MID CASE WITH ALTERNATE PARTS. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. - A REPLACEMENT DEVICE OF THE SAME MODEL WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: QUICK STRUTS WERE USED TO COMPLETE SURGERY. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 60 MINUTES. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. - COPY OF X-RAY IMAGES IS NOT AVAILABLE. - THE PROBLEM OCCURRED DURING THE FIRST USE OF THE DEVICE. - PATIENT'S CURRENT HEALTH CONDITION: PATIENT OUTCOME WAS SUCCESSFUL AT THIS MOMENT. NO ISSUES. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315441 TL,HINGE, UNIVERSAL TL,HINGE, UNIVERSAL LXT ORTHOFIX SRL B1816919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention