BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6456179 · Received April 4, 2017

    Report

    Report Number
    9680825-2017-00012
    Event Type
    Injury
    Date Received
    April 4, 2017
    Report Date
    April 3, 2017
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K152171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10100 BATCH V1395069 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, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE. TECHNICAL EVALUATION: THE DEVICE INVOLVED, RECEIVED ON MARCH 8TH, 2017 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK DID NOT REVEAL ANY SIGNS OF MARKS OR BREAKAGES, BUT THE DEVICE IS PARTLY FADED, PROBABLY DUE TO REPROCESSING CYCLES. THE FUNCTIONAL CHECK PERFORMED DID NOT EVIDENCE ANY ANOMALIES. THE DEVICE RETURNED IS STILL WORKING PROPERLY. AFTER THE TIGHTENING OF THE BOLT WITH A TORQUE, IT CAN BE CONFIRMED THAT THE STRUT REMAINS IN POSITION WITHOUT SLIPPING. THE BOLT THAT THE KEEPS THE ACUTE ADJUSTMENT WASHER COULD BE EASILY UNSCREWED USING A 10MM HEX WRENCH AND THEN THE INNER TUBE COULD SLIDE CORRECTLY INSIDE THE OUTER TUBE. PLEASE BE INFORMED THAT THE LOCKING BOLT IS RIVETED DURING ASSEMBLY TO AVOID DISMANTLING OF THE DEVICE. FOR THIS REASON, THE TRAVEL BETWEEN THE OPEN AND CLOSE POSITION IS VERY SHORT. THIS MAY LEAD TO THE FEELING THAT THE BOLT HAS ALREADY BEEN TIGHTENED, EVEN THOUGH THE INNER TUBE IS STILL SLIDING. WE MAY SUPPOSE THAT IN THIS CASE THE BOLT WAS FORCED IN OPENING, CAUSING THE RIVETED EXTREMITY OF THE BOLT TO GET STUCK IN THE THREADED HOLE. FROM THE RESULTS OF THE TECHNICAL ANALYSIS IT WAS CONFIRMED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX (B)(4) DESIGN SPECIFICATIONS AND THAT THE DEVICE IS STILL PERFORMING PROPERLY. ORTHOFIX (B)(4) TECHNICAL EVALUATION CAN CONCLUDE THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO INCORRECT APPLICATION. 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. ON (B)(6) 2017 IN THIS CASE A (B)(6) GIRL WAS HAVING A CORRECTION TO HER RIGHT TIBIA, USING THE ULTRA SHORT STRUTS BETWEEN TWO RING CONSTRUCTS. AT SOME STAGE POSTOPERATIVELY (NOT DEFINED) THE SIDE LOCKING BOLT OF ONE STRUT BECAME LOOSE, AND SOME CORRECTION WAS LOST. THE STRUT THEN JAMMED IN SOME WAY AND WAS REPLACED. A NEW CORRECTION PROGRAMME WAS CALCULATED AND THE TREATMENT IS CONTINUING AS ANTICIPATED. IT SEEMS MOST LIKELY THAT THE SIDE LOCKING BOLT HAD NOT BEEN TIGHTENED SUFFICIENTLY AT OPERATION. IT IS DIFFICULT TO IMAGINE ANOTHER REASON FOR THIS EVENT. ON (B)(6) 2017 WITH THE RESULTS OF THE TECHNICAL ANALYSIS: THIS TECHNICAL ANALYSIS SHOWS THAT THE STRUT IN QUESTION WAS PERFORMING NORMALLY. AS I STATED BEFORE, IT IS DIFFICULT TO THINK OF A REASON FOR THIS EXCEPT THAT THE BOLT WAS NOT TIGHTENED SUFFICIENTLY AT APPLICATION. THEREFORE, THIS FAILURE WAS DUE TO LOCAL TECHNICAL REASONS RELATING TO THIS CASE. FINAL COMMENTS: FROM THE RESULTS OF THE TECHNICAL ANALYSIS IT WAS CONFIRMED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX (B)(4) DESIGN SPECIFICATIONS AND THAT THE DEVICE IS STILL PERFORMING PROPERLY. ORTHOFIX (B)(4) TECHNICAL EVALUATION CAN CONCLUDE THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO INCORRECT APPLICATION. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: THIS TECHNICAL ANALYSIS SHOWS THAT THE STRUT IN QUESTION WAS PERFORMING NORMALLY. AS I STATED BEFORE, IT IS DIFFICULT TO THINK OF A REASON FOR THIS EXCEPT THAT THE BOLT WAS NOT TIGHTENED SUFFICIENTLY AT APPLICATION. THEREFORE, THIS FAILURE WAS DUE TO LOCAL TECHNICAL REASONS RELATING TO THIS CASE. 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 OPERATIVE REPORT AND COPIES OF X-RAY IMAGES. BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE DEVICE FAILED DUE TO THE CONDITIONS OF USE OF THE DEVICE. ORTHOFIX (B)(4) HISTORICAL RECORDS SHOWS THAT NO OTHER 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 INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: - HOSPITAL NAME: (B)(6); - SURGEON'S NAME: DR. (B)(6); - DATE OF SURGERY: (B)(6) 2017; - BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA RIGHT; - SURGERY DESCRIPTION: CORRECTION; - PATIENT INFORMATION: (B)(6), FEMALE, WEIGHT (B)(6), HEIGHT (B)(6); PREVIOUS HEALTH CONDITION: OK; - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; - EVENT DESCRIPTION: ACUTE SCREW WAS LOOSENED INDEPENDENTLY - CORRECTION LOSS AND PAIN. THE COMPLAINT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT -LOSS OF DISTRACTION/CORRECTION ACHIEVED; - THE SURGERY WAS NOT COMPLETED WITH THE DEVICE -POST OPERATIVE EVENT; - A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY -POST OPERATIVE EVENT; - DID THE EVENT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE? POST OPERATIVE EVENT; - AN ADDITIONAL SURGERY WAS NOT REQUIRED; - PATIENT CURRENT HEALTH CONDITION: OK. ON MARCH 27, 2017, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING FURTHER INFORMATION FROM THE LOCAL DISTRIBUTOR: "IT WAS NOT POSSIBLE TO BRING THE STRUT IN PLACE, BECAUSE OF A JAMMED ACUTE ADJUSTMENT PART. THEREFORE A NEW STRUT WAS USED. DUE TO THE DEFECT OF THE STRUT THE CORRECTION CHANGED AND A NEW PLANNING (PRESCRIPTION) WAS NECESSARY. IN MY INTERPRETATION THE REASON OF THE PROBLEM WAS A JAMMED LOCKING MECHANISMS, WHICH LEADS TO AN INADEQUATE CLOSURE. AFTER THE DISABLING OF THE STRUT IT WAS POSSIBLE TO MOVE THE "PLATE" OF THE CLOSING MECHANISM OF THE ACUTE ADJUSTMENT PART AND ALIGN IT. THEREFORE THE FAILURE IS NOT EXISTING ANYMORE, WHEN YOU CHECK THE STRUT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238011 ULTRA SHORT STRUT TL-HEX - 45MM-101MM ULTRA SHORT STRUT TL-HEX - 45MM-101MM KTT ORTHOFIX SRL 50-10100 V1395069

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention