BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TL PLUS HALF RING 180MM

    MDR report key: 12120055 · Received July 6, 2021

    Report

    Report Number
    9680825-2021-00051
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    February 12, 2021
    Report Date
    July 5, 2021
    Manufacturer
    ORTHOFIX SRL
    Product Code
    LXT
    PMA / PMN Number
    K941048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00020) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 56-14590 BATCH 1910066 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF 207 UNITS, ASSEMBLED IN SEVERAL BATCHES OF FINISHED DEVICE. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT (MFR 9680825-2021-00020). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 56-11650 BATCH 2001711 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2020, WAS COMPRISED OF 83 UNITS, ASSEMBLED IN SEVERAL BATCHES OF FINISHED DEVICE. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00020). THE RETURNED DEVICES, RECEIVED ON (B)(6) 2021, WERE EXAMINED BY ORTHOFIX SRL QUALITY OPERATION DEPARTMENT. IN RELATION TO THIS EVENT, ORTHOFIX RECEIVED THE FOLLOWING DEVICES: TWO TL+ FOOT PLATE EXTENSION 5 HOLE CODE 56-14590 BATCH 1910066. ONE TL PLUS HALF RING 180MM CODE 56-11650 BATCH 2001711. TWO TL,BOLT, WIRE FIXATION, UNIVERSAL CODE 54-1152 BATCH AF3976 AND AF3988. FROM A VISUAL EXAMINATION, IT WAS DETERMINED THAT ONLY ONE TL+ FOOT PLATE EXTENSION 5 HOLE CODE 56-14590 BATCH 1910066 AND ONE TL PLUS HALF RING 180MM CODE 56-11650 BATCH 2001711 PRESENTED ANOMALIES. THE OTHER DEVICES DID NOT SHOW ANY ISSUES. THE AFFECTED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. TL+ FOOT PLATE EXTENSION CODE 56-14590 BATCH 1910066 (MFR 9680825-2021-00020) THE VISUAL CHECK CONFIRMED THAT THE DEVICE IS BROKEN IN CORRESPONDENCE OF THE HOLE. FROM A VISUAL EXAMINATION OF THE BROKEN SURFACES, IT WAS CONCLUDED THAT THE DEVICE BROKE DUE TO FLEXURAL OVERLOAD. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS ALSO PERFORMED THE DOCUMENTAL CHECK OF THE RAW MATERIAL CERTIFICATE USED TO PRODUCE THIS DEVICE. NO PROBLEM WAS FOUND. TL PLUS HALF RING 180MM CODE 56-11650 BATCH 2001711 (MFR 9680825-2021-00051) THE VISUAL CHECK CONFIRMED THAT THE DEVICE IS CRACKED IN CORRESPONDENCE OF THE HOLE, AT THE CONNECTION WITH THE FOOT PLATE EXTENSION. FROM A VISUAL EXAMINATION OF THE CRACKING SURFACES, IT WAS CONFIRMED FLEXURAL OVERLOAD ACTING ON THE DEVICE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS ALSO PERFORMED THE DOCUMENTAL CHECK OF THE RAW MATERIAL CERTIFICATE USED TO PRODUCE THIS DEVICE. NO PROBLEM WAS FOUND. MEDICAL EVALUATION (MFR REPORTS 9680825-2021-00020) THE INFORMATION MADE AVAILABLE ON THE EVENT OVER THE TIME TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. "IN THIS CASE A PATIENT WITH CHARCOT ANKLE WAS BEING TREATED WITH A TRUELOK FRAME WITH A FOOTPLATE EXTENSION CODE 56-14590. THE FIRST OPERATION WAS ON FEB 3RD 2021, AND THE ITEM BROKE AND HAD A REOPERATION ON MARCH 1ST. WE KNOW NO MORE AT PRESENT. THE PATIENT DENIES WEIGHTBEARING. WE KNOW THAT THE FRAME WAS REBUILT WITH NEW COMPONENTS. WE DO NOT KNOW IF THE PATIENT REQUIRED A GENERAL ANAESTHETIC FOR THIS, BUT THE PATIENT IS NOW IN A GOOD CONDITION. THE TECHNICAL REPORT MAKES IT CLEAR THAT THE EXTENSION PLATES WERE SUBJECTED TO AN ABNORMAL LOAD, WHICH IS REFLECTED IN MATCHING CRACKS IN THE RING. THE DESIGN OF THE FRAME RESULTED IN THE EXTENSION PLATE FIXATION BOLTS CARRYING ALL THE LOAD. A SUGGESTION IS MADE AS TO HOW THE DESIGN CAN BE ADJUSTED TO SPREAD THE LOAD, WHICH WOULD SURELY HAVE PREVENTED THIS BREAKAGE". CONCLUSION (MFR REPORTS 9680825-2021-00020) THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT BOTH DEVICES CRACKED OR BROKE NEXT TO THE HOLE. FROM THE ANALYSIS OF THE FRACTURE SURFACE, IT WAS CONCLUDED THAT THE FAILURE OCCURRED IS MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD. TO IMPROVE THE FRAME MECHANICAL STRENGTH IT IS SUGGESTED TO FOLLOW THE STEPS REPORTED IN THE OPERATIVE TECHNIQUE TL-0922 "ANKLE ARTHRODESIS USING THE TRUELOK FIXATION SYSTEM". A COMPLETE MEDICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS SOME INFORMATION ABOUT THE MEDICAL PROCEDURE WAS NOT MADE AVAILABLE, I.E. COPIES OF THE X-RAY IMAGES. BASED ON THE RESULTS OF THE TECHNICAL INVESTIGATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS MAINLY DUE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD RELATED TO THIS SPECIFIC APPLICATION. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 56-14590 (TL+ FOOT PLATE EXTENSION 5 HOLE). BATCH NUMBER: 1910066. QUANTITY: 1. DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT FOOT. SURGERY DESCRIPTION: CHARCOT FOOT. PATIENT'S INFORMATION: FEMALE. EVENT DESCRIPTION: "THE FOOT EXTENSION IS BROKEN AT THE CONNECTION TO THE HALF-RING". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2021). COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. FURTHER INFORMATION RECEIVED ON MARCH, 2021 FROM THE LOCAL DISTRIBUTOR: BATCH NUMBER OF THE BROKEN DEVICE: 1910066 DATE OF THE DEVICE BREAKAGE: 12/02/2021 DURING THE ADDITIONAL SURGERY, DONE LAST MARCH 1, IT WAS EXCHANGED THE BROKEN PART AND REBUILT THE FRAME CURRENT HEALTH CONDITION OF THE PATIENT: PATIENT IS IN GOOD CONDITIONS. FROM THE RESULTS OF THE TECHNICAL ANALYSIS, RECEIVED ON (B)(6) 2021, IT WAS DETERMINED THAT THE DEVICES INVOLVED IN THIS INCIDENT ARE TWO: ONE TL FOOT PLATE EXTENSION 5 HOLE CODE 56-14590 BATCH 1910066 (MFR REPORT 9680825-2021-00020) MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016548 TL PLUS HALF RING 180MM TL PLUS HALF RING 180MM LXT ORTHOFIX SRL 2001711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention