BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SHORT STRUT TL-HEX - 45MM-101MM

    MDR report key: 5966570 · Received September 21, 2016

    Report

    Report Number
    9680825-2016-00078
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    May 3, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K152171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS BEEN DISCARDED BY THE HOSPITAL. UNFORTUNATELY ALSO THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE BROKEN DEVICE USED WAS NOT POSSIBLE AS THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS ONGOING AND WILL BE FINALIZED ONCE FURTHER INFORMATION WILL BE AVAILABLE. ORTHOFIX (B)(4) HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS DATE OF INITIAL SURGERY, DATE OF DEVICE FAILURE, COPIES OF THE OPERATIVE REPORTS, TL-HEX SOFTWARE DETAILS AND COPY OF THE SOFTWARE PRESCRIPTION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. DEVICE DISCARDED AT THE DOCTOR'S OFFICE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS : THE DEVICE INVOLVED IN THIS EVENT HAS BEEN DISCARDED BY THE HOSPITAL. UNFORTUNATELY, ALSO THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE BROKEN DEVICE USED WAS NOT POSSIBLE AS THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. SEPTEMBER 22, 2016: "THIS PATIENT HAS A CHARCOT FOOT. THIS MEANS THAT THE PATIENT WILL NOT HAVE THE USUAL SENSATION FROM THE FOOT WHICH IN UNDISEASED PEOPLE PROVIDE INFORMATION ABOUT EXCESSIVE LOADING. IT WILL HAVE BEEN VERY EASY FOR THIS PATIENT TO OVERLOAD THIS COMPONENT. I NOTE THE VERY IMPRESSIVE SERIES OF IMAGES WHICH DETAIL EVERY ASPECT OF THIS TREATMENT. THIS PATIENT HAS A LISFRANC'S DISLOCATION SECONDARY TO THE CHARCOT DISEASE, AND IT HAS BEEN MANAGED VERY NICELY BY THIS SURGEON. THIS IS VERY GOOD WORK. THIS COMPONENT WILL HAVE BEEN OVERLOADED BECAUSE OF THE PATIENT'S CONDITION.". SEPTEMBER 28, 2016 WITH THE FURTHER INFORMATION RECEIVED ON SEPTEMBER 21, "I SUSPECT THAT AS THE STRUT CONCERNED WAS FULLY EXTENDED IT WAS THE LEAST ABLE TO WITHSTAND THE EXCESSIVE LOAD CAUSED BY THE PATIENT HAVING A CHARCOT JOINT. OVERLOADING A FRAME IS ALWAYS MORE LIKELY WITH A CHARCOT JOINT, AND PATIENTS SHOULD BE ADVISED ACCORDINGLY". OCTOBER 12, 2016 WITH THE OPERATIVE REPORT: "THIS SURGEON HAS PROVIDED A REALLY EXCELLENT RECORD OF THE PROGRESS OF THIS PATIENT. IN THE PREAMBLE TO THE OPERATIVE REPORT HE HAS STATED THAT HE ANTICIPATES THAT VARIOUS COMPLICATIONS ARE POSSIBLE, AND GAVE THIS INFORMATION TO THE PATIENT. THIS IS A VERY COMPLEX PIECE OF FOOT AND ANKLE SURGERY, ATTEMPTING TO SALVAGE A FUNCTIONING LOWER LIMB IN A PATIENT WITH LONG STANDING CHARCOT FOOT. THE BENDING AND BREAKAGE OF THIS STRUT WERE A MINOR EPISODE IN THIS COMPLEX TREATMENT, AND RAPIDLY CORRECTED BY STRUT REPLACEMENT. THE AIMS OF THE SURGERY ARE BEING ACHIEVED, AND THE STRUT FAILURE DID NOT INTERRUPT THIS SIGNIFICANTLY. THE STRUT OVERLOAD HAPPENED BECAUSE OF THE PARTICULAR FRAME DESIGN AND THE INEVITABLE OVERLOADING OF THE FRAME THAT IS CONSEQUENT ON THE PATHOLOGY. THIS CONFIRMS THAT THE STRUT WAS LOADED BEYOND THE DESIGN CRITERIA AND BENT AND THEN FAILED." FINAL COMMENTS: A TECHNICAL EVALUATION OF THE BROKEN DEVICE USED WAS NOT POSSIBLE AS THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "THIS PATIENT HAS A CHARCOT FOOT. THIS MEANS THAT THE PATIENT WILL NOT HAVE THE USUAL SENSATION FROM THE FOOT WHICH IN UNDISEASED PEOPLE PROVIDE INFORMATION ABOUT EXCESSIVE LOADING. IT WILL HAVE BEEN VERY EASY FOR THIS PATIENT TO OVERLOAD THIS COMPONENT. I NOTE THE VERY IMPRESSIVE SERIES OF IMAGES WHICH DETAIL EVERY ASPECT OF THIS TREATMENT. THIS PATIENT HAS A LISFRANC'S DISLOCATION SECONDARY TO THE CHARCOT DISEASE, AND IT HAS BEEN MANAGED VERY NICELY BY THIS SURGEON. THIS IS VERY GOOD WORK. THIS COMPONENT WILL HAVE BEEN OVERLOADED BECAUSE OF THE PATIENT'S CONDITION. I SUSPECT THAT AS THE STRUT CONCERNED WAS FULLY EXTENDED IT WAS THE LEAST ABLE TO WITHSTAND THE EXCESSIVE LOAD CAUSED BY THE PATIENT HAVING A CHARCOT JOINT. OVERLOADING A FRAME IS ALWAYS MORE LIKELY WITH A CHARCOT JOINT, AND PATIENTS SHOULD BE ADVISED ACCORDINGLY. THIS SURGEON HAS PROVIDED A REALLY EXCELLENT RECORD OF THE PROGRESS OF THIS PATIENT. IN THE PREAMBLE TO THE OPERATIVE REPORT HE HAS STATED THAT HE ANTICIPATES THAT VARIOUS COMPLICATIONS ARE POSSIBLE, AND GAVE THIS INFORMATION TO THE PATIENT. THIS IS A VERY COMPLEX PIECE OF FOOT AND ANKLE SURGERY, ATTEMPTING TO SALVAGE A FUNCTIONING LOWER LIMB IN A PATIENT WITH LONG STANDING CHARCOT FOOT. THE BENDING AND BREAKAGE OF THIS STRUT WERE A MINOR EPISODE IN THIS COMPLEX TREATMENT, AND RAPIDLY CORRECTED BY STRUT REPLACEMENT. THE AIMS OF THE SURGERY ARE BEING ACHIEVED, AND THE STRUT FAILURE DID NOT INTERRUPT THIS SIGNIFICANTLY. THE STRUT OVERLOAD HAPPENED BECAUSE OF THE PARTICULAR FRAME DESIGN AND THE INEVITABLE OVERLOADING OF THE FRAME THAT IS CONSEQUENT ON THE PATHOLOGY. THIS CONFIRMS THAT THE STRUT WAS LOADED BEYOND THE DESIGN CRITERIA AND BENT AND THEN FAILED". BASED ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE FAILURE THAT OCCURRED IS MOST LIKELY RELATED TO THE OVERLOAD CAUSED BY THE PATIENT'S CONDITION. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. DEVICE DISCARDED AT THE DOCTOR'S OFFICE.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10100 (ULTRA SHORT STRUT TL-HEX - 45MM-101MM). BATCH NUMBER: UNKNOWN. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6). DATE OF SURGERY: NOT PROVIDED. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT. TYPE OF PROBLEM: PACKAGING OR LABELLING PROBLEM (INFORMATION UNDER VERIFICATION). EVENT DESCRIPTION: 50-10100X1 (ULTRA SHORT HEX STRUT) THREADED ROD BROKE. PATIENT WAS PARTIAL. WEIGHT-BEARING/WALKING ON FRAME. THE ROD WAS EXTENDED AND BENT, THEN BROKE. THIS WAS NOT DURING A SURGERY. IT BROKE ON THE DAY IT WAS DUE TO BE REPLACED WITH A LONGER STRUT AND SO IT WAS SWAPPED OUT AND DISCARDED AT THE DOCTOR'S OFFICE. CHARCOT DEFORMITY CORRECTION W/HEXAPOD FIXATOR. -PATIENT CONDITION CHARCOT FOOT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT . THE SURGERY WAS COMPLETED WITH DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. COPIES OF THE OPERATIVE REPORTS ARE AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT WENT ON TO SUCCESSFUL CORRECTION AND FRAME REMOVAL. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10100 (ULTRA SHORT STRUT TL-HEX - 45MM-101MM) BATCH NUMBER: UNKNOWN QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6), DPM. DATE OF SURGERY: NOT PROVIDED. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT. TYPE OF PROBLEM: PACKAGING OR LABELLING PROBLEM (INFORMATION UNDER VERIFICATION). EVENT DESCRIPTION: 50-10100X1 (ULTRA SHORT HEX STRUT) THREADED ROD BROKE. PATIENT WAS PARTIAL WEIGHT-BEARING/WALKING ON FRAME. THE ROD WAS EXTENDED AND BENT, THEN BROKE. THIS WAS NOT DURING A SURGERY. IT BROKE ON THE DAY IT WAS DUE TO BE REPLACED WITH A LONGER STRUT AND SO IT WAS SWAPPED OUT AND DISCARDED AT THE DOCTOR'S OFFICE. CHARCOT DEFORMITY CORRECTION W/HEXAPOD FIXATOR. PATIENT CONDITION CHARCOT FOOT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. COPIES OF THE OPERATIVE REPORTS ARE AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT WENT ON TO SUCCESSFUL CORRECTION AND FRAME REMOVAL. ON SEPTEMBER 21, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL DATE OF SURGERY WAS (B)(6) 2016 WITH PT (B)(6). THE REP WILL REVIEW HIS RECORDS FOR THE DATE OF THE DEVICE FAILURE. THE REP CONFIRMED THAT THE STRUT BENT WHILE THE PATIENT WAS AT HOME. THE PART WAS CHANGED OUT IN THE DOCTOR'S OFFICE AND NOT IN THE OR. CURRENTLY, HE DOES NOT HAVE TO THE PRESCRIPTION AND SOFTWARE DETAILS. THE STRUT WAS BEING REPLACED WITH A BIGGER STRUT BECAUSE THE 50-10100 HAD REACHED IS MAXIMUM EXTENSION. SINCE IT WAS FULLY EXTENDED AND THE PATIENT WAS WEIGHT BEARING THE STRUT BECAME WEAK AND THEN BENT. A REQUEST FOR THE OPERATIVE REPORTS WAS MADE. THE REP IS GOING TO TRY TO AND SEE IF HE CAN ACCESS THE PRESCRIPTION AND SOFTWARE DETAILS. HE WILL ALSO TRY TO PROVIDE THE DATE OF THE DEVICE FAILURE. ON SEPTEMBER 28, 2016, ORTHOFIX (B)(4) RECEIVED COPIES OF THE OPERATIVE REPORT AND THE FOLLOWING ADDITIONAL INFORMATION: THE REP BELIEVES THAT THE STRUT BROKE AROUND MAY 3 AND WAS SWITCHED OUT RIGHT AWAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619307 ULTRA SHORT STRUT TL-HEX - 45MM-101MM ULTRA SHORT STRUT TL-HEX - 45MM-101MM KTT ORTHOFIX SRL 50-10100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1