BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORT STRUT TL-HEX - 92MM-122MM

    MDR report key: 5767885 · Received July 4, 2016

    Report

    Report Number
    9680825-2016-00055
    Event Type
    Injury
    Date Received
    July 4, 2016
    Report Date
    August 8, 2016
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K141078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10200 LOT V1391038 (LOT LASER MARKED ON THE COMPONENT V1390298) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF 20 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICE IS CURRENTLY ON GOING. MEDICAL EVALUATION: THE INFORMATION AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE TECHNICAL INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. DEVICE CURRENTLY UNDER TECHNICAL EVALUAT...

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10200 LOT V1391038 (LOT LASER MARKED ON THE COMPONENT V1390298) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON JUNE 8TH, 2016 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) DESIGN AND PRODUCT SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE DEVICE IS SLIGHTLY DISCOLOURED. THERE ARE ALSO SIGNS OF NORMAL WEAR DUE TO THE USE ON THE DEVICE'S SURFACE. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. THE DEVICE WAS THEN SUBJECTED TO A FUNCTIONAL TEST UNDER TENSION LOAD AS PER VALIDATION PROTOCOL. THE DEVICE TESTED MET THE DESIGN SPECIFICATION. THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE DEVICE STILL PERFORMS PROPERLY. THE FAILURE NOTIFIED IS MOST LIKELY TO BE RELATED TO APPLICATION ISSUES. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. "THE TECHNICAL EVALUATION SHOWS THAT THE DEVICE WOULD IN FACT PERFORM ACCORDING TO SPECIFICATIONS IF TIGHTENED CORRECTLY. I AGREE WITH THE CONCLUSIONS THAT THE DEVICE FAILED BECAUSE OF PARTICULAR CIRCUMSTANCES RELATING TO THE APPLICATION". FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE DEVICE STILL PERFORMS PROPERLY. THE FAILURE NOTIFIED IS MOST LIKELY TO BE RELATED TO APPLICATION ISSUES. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "THE TECHNICAL EVALUATION SHOWS THAT THE DEVICE WOULD IN FACT PERFORM ACCORDING TO SPECIFICATIONS IF TIGHTENED CORRECTLY. I AGREE WITH THE CONCLUSIONS THAT THE DEVICE FAILED BECAUSE OF PARTICULAR CIRCUMSTANCES RELATING TO THE APPLICATION". ORTHOFIX (B)(4) HISTORICAL RECORDS SHOWS THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10200 (SHORT STRUT TL-HEX - 92MM-122MM). BATCH NUMBER: V1390298. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA RIGHT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6), MALE, (B)(6), PREVIOUS HEALTH CONDITIONS: GOOD. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: DURING THE CORRECTION, THE STRUT COULD NOT KEEP THE ACUTE AREA. THAT MEANS THE STRUT IS SLIDING REPEATEDLY. THAT'S WHY THE CORRECTION DOESN'T FOLLOW THE PLAN AND GENERATES ANOTHER DEFORMITY DURING THE TREATMENT. WITH A NEW STRUT AND A NEW CORRECTION PLAN WE SOLVE THE PROBLEMS IN THE TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH USED DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT IS HEALTHY. WE MONITOR THE SITUATION OVER 4 WEEKS AND REPLACE THE STRUT THEN IMMEDIATELY. THE CORRECTION IS NOT EXTENDED OF THIS PROBLEM, BECAUSE WE HAVE STILL 5 CM LENGTHENING LEFT. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10200 (SHORT STRUT TL-HEX - 92MM-122MM), BATCH NUMBER: V1390298, QUANTITY: 1, HOSPITAL NAME: (B)(6), SURGEON'S NAME: DR. (B)(6), DATE OF SURGERY: (B)(6) 2016, BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA RIGHT, SURGERY DESCRIPTION: CORRECTION, PATIENT INFORMATION: (B)(6), MALE, (B)(6), PREVIOUS HEALTH CONDITIONS: GOOD, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM, EVENT DESCRIPTION: DURING THE CORRECTION, THE STRUT COULD NOT KEEP THE ACUTE AREA. THAT MEANS THE STRUT IS SLIDING REPEATEDLY. THAT'S WHY THE CORRECTION DOESN'T FOLLOW THE PLAN AND GENERATES ANOTHER DEFORMITY DURING THE TREATMENT. WITH A NEW STRUT AND A NEW CORRECTION PLAN WE SOLVE THE PROBLEMS IN THE TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH USED DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT IS HEALTHY. WE MONITOR THE SITUATION OVER 4 WEEKS AND REPLACE THE STRUT THEN IMMEDIATELY. THE CORRECTION IS NOT EXTENDED OF THIS PROBLEM, BECAUSE WE HAVE STILL 5 CM LENGTHENING LEFT. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421960 SHORT STRUT TL-HEX - 92MM-122MM SHORT STRUT TL-HEX - 92MM-122MM KTT ORTHOFIX SRL 50-10200 V1391038

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention