BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOTITE BONE SCREW 120/20 MM SHAFT D 6MM THREAD D 4.5-3.5MM

    MDR report key: 5196896 · Received November 3, 2015

    Report

    Report Number
    9680825-2015-00051
    Event Type
    Injury
    Date Received
    November 3, 2015
    Date of Event
    September 24, 2015
    Report Date
    November 30, 2015
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K974186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 99-60137 LOT V1366480 (LOT LASER-MARKED ON THE COMPONENT G198) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN APRIL 2014, WAS COMPRISED OF 60 UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED WAS RECEIVED BY ORTHOFIX SRL ON (B)(4) 2015. THE TECHNICAL EVALUATION ON THE RETURNED DEVICE IS CURRENTLY ON GOING. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION IS CURRENTLY ON GOING AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION AND/OR FURTHER INFORMATION ON THE CASE ARE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS (INFORMATION ALREADY PROVIDED) (B)(4). ORTHOFIX FAILURE ANALYSIS CAN CONCLUDE THAT THE BREAKAGE OF THE DEVICE INVOLVED COULD BE MAINLY ATTRIBUTABLE TO A TORSIONAL OVERLOAD FRACTURE. MEDICAL EVALUATION (NEW INFORMATION) THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION, WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION: "THIS PATIENT IS A (B)(6) MALE, AND HE IS HAVING A GALAXY ELBOW FIXATOR APPLIED. 2 X 6.0 MM SCREWS HAVE BEEN INSERTED INTO THE HUMERUS, AND 2 X 4.5 - 3.5 MM SCREWS INTO THE ULNA, AS RECOMMENDED. UNFORTUNATELY THE SECOND ULNA SCREW BROKE WHILE BEING INSERTED. WHAT IS VERY STRANGE IS THAT THE SURGEON APPARENTLY ELECTED TO LEAVE JUST ONE SCREW IN THE ULNA, BUT CAME BACK 4 DAYS LATER TO INSERT A SECOND SCREW. WE KNOW FROM EXTENSIVE EXPERIENCE THAT IT IS NOT DIFFICULT TO BREAK A 4.5 TO 3.5 MM BONE SCREW IF THE SURGEON IS NOT VERY CAREFUL ABOUT THE INSERTION TORQUE. IT LOOKS TO HAVE BEEN A NICE APPLICATION, AND IT IS BAD LUCK THAT THIS SCREW BROKE. HOWEVER, THE VERY STRANGE DECISION NOT TO INSERT A THIRD ULNA SCREW WAS RESPONSIBLE FOR THE SECOND OPERATION. THIS WAS NOT THE FAULT OF THE BROKEN SCREW. THIS BONE SCREW BROKE BECAUSE OF A TORSIONAL OVERLOAD AS ANTICIPATED. THE TECHNICAL ANALYSIS SHOWS THAT THE STRUCTURE AND COMPOSITION WERE WITHIN SPECIFICATION. THIS WAS UNFORTUNATE AND THERE IS NO OBVIOUS IMMEDIATE CAUSE. HOWEVER, SOME SURGEONS ARE INCLINED TO INSERT THE BONE SCREWS VERY FAST EVEN WHEN THEY DO IT BY HAND. THIS DOES NOT ALLOW THE SURGEON TO FEEL RESISTANCE AND STOP INSERTION BEFORE A BREAKAGE OCCURS. THE NEED FOR A SECOND SURGERY IN THIS CASE WAS BECAUSE THE SURGEON DID NOT INSERT ANOTHER ULNAR SCREW AT THE TIME. I AGREE THAT WHAT PROBABLY HAPPENED WAS THAT THE SURGEON WAS INSERTING THE SCREW AND FOUND IT TO BE WORRYINGLY TIGHT (AND PROBABLY DURING THIS BEGAN THE PROCESS OF TORSIONAL OVERLOAD WITH PERHAPS SOME PLASTIC DEFORMATION). HE THEN UNSCREWS THE SCREW; BECAUSE IT IS SO TIGHT, THIS COMPLETES THE OVERLOAD AND CAUSES A SHEAR WITH A FINAL TORSIONAL OVERLOAD IN AN ANTICLOCKWISE DIRECTION." MANUFACTURER FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE BREAKAGE OF THE DEVICE INVOLVED COULD BE MAINLY ATTRIBUTABLE TO A TORSIONAL OVERLOAD FRACTURE. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "WE KNOW FROM EXTENSIVE EXPERIENCE THAT IT IS NOT DIFFICULT TO BREAK A 4.5 TO 3.5 MM BONE SCREW IF THE SURGEON IS NOT VERY CAREFUL ABOUT THE INSERTION TORQUE. THIS BONE SCREW BROKE BECAUSE OF A TORSIONAL OVERLOAD AS ANTICIPATED. THE TECHNICAL ANALYSIS SHOWS THAT THE STRUCTURE AND COMPOSITION WERE WITHIN SPECIFICATION. THIS WAS UNFORTUNATE AND THERE IS NO OBVIOUS IMMEDIATE CAUSE. HOWEVER, SOME SURGEONS ARE INCLINED TO INSERT THE BONE SCREWS VERY FAST EVEN WHEN THEY DO IT BY HAND. THIS DOES NOT ALLOW THE SURGEON TO FEEL RESISTANCE AND STOP INSERTION BEFORE A BREAKAGE OCCURS. THE NEED FOR A SECOND SURGERY IN THIS CASE WAS BECAUSE THE SURGEON DID NOT INSERT ANOTHER ULNAR SCREW AT THE TIME. I AGREE THAT WHAT PROBABLY HAPPENED WAS THAT THE SURGEON WAS INSERTING THE SCREW AND FOUND IT TO BE WORRYINGLY TIGHT (AND PROBABLY DURING THIS BEGAN THE PROCESS OF TORSIONAL OVERLOAD WITH PERHAPS SOME PLASTIC DEFORMATION). HE THEN UNSCREWS THE SCREW; BECAUSE IT IS SO TIGHT, THIS COMPLETES THE OVERLOAD AND CAUSES A SHEAR WITH A FINAL TORSIONAL OVERLOAD IN AN ANTICLOCKWISE DIRECTION." PLEASE FIND BELOW AN EXTRACT FROM ORTHOFIX SRL INSTRUCTION FOR USE LEAFLET REF. PQ SCR ORTHOFIX BONE SCREWS FOR EXTERNAL FIXATION SYSTEM (WARNINGS §10.) : "SCREW INSERTION, WHETHER OR NOT PRE-DRILLING HAS BEEN PERFORMED, SHOULD ALWAYS BE WITH THE HAND DRILL OR T-WRENCH ONLY AND THROUGH A SCREW GUIDE. IT IS IMPORTANT THAT MODERATE FORCE IS APPLIED FOR THE SCREW TO GAIN ENTRY INTO THE FIRST CORTEX. INSERTION CAN BE COMPLETED WITH THE T-WRENCH. DIAPHYSEAL BONE SCREWS SHOULD ALWAYS BE INSERTED IN THE CENTRE OF THE BONE AXIS, TO AVOID WEAKENING IT. IN ALL CASES THE SURGEON SHOULD BE MINDFUL OF THE AMOUNT OF TORQUE REQUIRED TO INSERT THE SCREW. IF IT SEEMS TIGHTER THAN USUAL, IT IS SAFER TO REMOVE THE SCREW AND CLEAN IT, AND DRILL THE HOLE AGAIN." BASED ON THE RESULTS OF THE TECHNICAL EVALUATION PERFORMED ON THE RETURNED DEVICE, THAT EVIDENCED THAT THE TYPE OF BREAKAGE COULD BE MAINLY ATTRIBUTABLE TO A TORSIONAL OVERLOAD FRACTURE, AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM OCCURRED IS NOT DEVICE RELATED. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2015; BODY PART TO WHICH DEVICE WAS APPLIED: ELBOW; SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: (B)(6) MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT / INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "AN ELBOW GALAXY FIXATOR HAS BEEN IMPLANTED ON PATIENT. THERE WAS NO PROBLEM WITH FIRST BONE SCREW BUT SECOND ONE GOT BROKEN AT EXTREMITY IN PATIENT BONE. IT WAS MANUALLY IMPLANTED AND OPERATOR PERFORMED PRE DRILLING. IT WAS DECIDED TO KEEP SCREW PIECE IN PATIENT BONE. BY MONDAY (B)(6), A SECOND SURGERY OCCURRED TO IMPLANT SECOND BONE SCREW. IT WAS NECESSARY TO WIDEN INITIAL CUT." THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE SURGERY COULD NOT BE COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED -PERFORMED ON (B)(6) 2015. COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF X-RAY IMAGES ARE AVAILABLE. INFORMATION ON PATIENT'S CURRENT HEALTH CONDITION: PATIENT IS OK WITH CORRECTION ON THE WAY. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2015; BODY PART TO WHICH DEVICE WAS APPLIED: ELBOW; SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: (B)(6), MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT / INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "AN ELBOW GALAXY FIXATOR HAS BEEN IMPLANTED ON PATIENT. THERE WAS NO PROBLEM WITH FIRST BONE SCREW BUT SECOND ONE GOT BROKEN AT EXTREMITY IN PATIENT BONE. IT WAS MANUALLY IMPLANTED AND OPERATOR PERFORMED PRE DRILLING. IT WAS DECIDED TO KEEP SCREW PIECE IN PATIENT BONE. BY MONDAY (B)(6), A SECOND SURGERY OCCURRED TO IMPLANT SECOND BONE SCREW. IT WAS NECESSARY TO WIDEN INITIAL CUT." THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE SURGERY COULD NOT BE COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED -PERFORMED ON (B)(6) 2015. COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF X-RAY IMAGES ARE AVAILABLE. INFORMATION ON PATIENT'S CURRENT HEALTH CONDITION: PATIENT IS OK WITH CORRECTION ON THE WAY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728184 OSTEOTITE BONE SCREW 120/20 MM SHAFT D 6MM THREAD D 4.5-3.5MM OSTEOTITE BONE SCREW 120/20 MM SHAFT D 6MM THREAD D 4.5-3.5MM JDW ORTHOFIX SRL 99-60137 V1366480

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention