BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM

    MDR report key: 7599897 · Received June 14, 2018

    Report

    Report Number
    9680825-2018-00047
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 21, 2018
    Report Date
    July 24, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K974186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE: 99-60138, LOT: V1382507 (LOT MARKED ON THE SCREW IS G156) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF 60 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE: 99-60138, LOT: V1389095 (LOT MARKED ON THE SCREW IS G161) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF 60 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2018-00048). TECHNICAL EVALUATION: THE BROKEN SCREWS, RECEIVED ON JUNE 25, 2018, WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE RETURNED BONE SCREWS WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED, BOTH SCREWS ARE BROKEN AT ABOUT ONE THIRD OF THE THREADED PORTION. THE DIMENSIONAL CHECK CONFIRMED THAT THE BROKEN SCREWS ARE CONFORMING TO ORTHOFIX SPECIFICATIONS. A FUNCTIONAL CHECK ON THE RETURNED SCREWS WAS NOT POSSIBLE AS THE DEVICES ARE BROKEN AND THEREFORE NOT FUNCTIONING. THE DEVICES WERE THEN SENT TO AN EXTERNAL LABORATORY FOR THE RAW MATERIAL CHECK AND THE FAILURE ANALYSIS. FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONFIRMED THE DEVICES CONFORMITY TO DESIGN SPECIFICATION. BOTH SCREWS FAILED DUE TO TORSIONAL OVERLOAD. 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. JUNE 3, 2018: "99-60138 BONE SCREWS ARE STERILE PACKED 120/30 SCREWS, WITH 6 MM SHANK AND 4.5/3.5 MM DIAMETER TAPERED THREAD WITH OSTEOTITE COATING. THESE SCREWS WERE BEING INSERTED INTO THE TIBIA OF A 12 YEAR OLD FEMALE PATIENT AS PART OF THE APPLICATION OF A TL-HEX FRAME. I THINK THAT ONE SCREW BROKE DURING INSERTION AND THE OTHER AT THE END OF INSERTION. ANYWAY, QUITE A FEW DETAILS THAT MIGHT HELP US UNDERSTAND THIS EVENT ARE MISSING: THE HEIGHT AND WEIGHT OF THE PATIENT ARE IMPORTANT BECAUSE THEY GIVE US A CLUE TO THE SIZE AND MATURITY OF THE TIBIA. WE DO NOT AS YET KNOW IF THIS SIZE OF BONE SCREW WAS APPROPRIATE FOR THIS PATIENT. BREAKAGES TEND TO OCCUR WHEN THIS SIZE OF SCREW IS USED IN YOUNG PATIENTS WHO ARE NEARLY OF ADULT SIZE. IT WOULD ALSO BE USEFUL TO KNOW IF THE SCREWS WERE BEING INSERTED BY HAND OR WITH A POWER TOOL". JUNE 8, 2018 WITH THE ADDITIONAL INFORMATION RECEIVED ON JUNE 6, 2018: "THE 12 YEAR OLD PATIENT WEIGHS 68 KG AND 1.57 METERS TALL, SO SHE IS VERY MUCH OF ADULT PROPORTIONS. LOOKING AT THE X-RAYS, ONE SCREW HAS BROKEN AS IT ENGAGED THE SECOND CORTEX, AND THE OTHER AS IT NEARED FULL INSERTION. I RECKON THAT THE TIBIA IS AT LEAST 23 MM IN DIAMETER AT THIS POINT, AND THE CORTEX LOOKS THICK. WITHOUT QUESTION THIS FIXATION WOULD HAVE BEEN BETTER WITH ADULT SIZED BONE SCREWS, ESPECIALLY AS IT WAS INTO TIBIAL CORTICAL BONE. THE BONE SCREWS WERE TOO SMALL FOR THE APPLICATION AND WERE LOADED BEYOND THEIR DESIGN CRITERIA". JULY 20, 2018 WITH THE RESULTS OF THE TECHNICAL ANALYSIS: "THE TECHNICAL ANALYSIS SHOWS RESULTS THAT ARE VERY MUCH AS EXPECTED, AND CONFIRMS THAT THE CAUSE OF THESE 2 SCREW FAILURES WAS ACUTE TORSIONAL OVERLOAD, CAUSED BY THE SCREW BEING INSERTED INTO A BONE THAT IS TOO BIG FOR ITS SIZE. AS NOTED BEFORE, THE SURGEON SHOULD HAVE USED 6 / 5MM THREADED BONE SCREWS, AND THIS WOULD NOT HAVE HAPPENED". FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE RETURNED SCREWS WERE CONFORMING TO DESIGN SPECIFICATION. BOTH SCREWS FAILED DUE TO TORSIONAL OVERLOAD. ACCORDING TO THE INFORMATION PROVIDED ON THE CASE AND AS A RESULT OF THE INVESTIGATION PERFORMED, ORTHOFIX SRL CAN CONCLUDE THAT THE SCREWS WERE SUBJECTED TO TORSIONAL OVERLOAD DURING INSERTION WHICH CAUSED THEM TO BREAK. THE BREAKAGE IS RELATED TO THE INADEQUATE SCREW SIZE SELECTED. THE BREAKAGE IS THEREFORE NOT DEVICE RELATED. ORTHOFIX SRL WOULD LIKE TO REMIND THE IMPORTANCE OF METICULOUSLY FOLLOWING THE INSTRUCTIONS FOR USE (REF: TO (B)(4), WHERE DETAILED INFORMATION ARE REPORTED REGARDING SCREW SELECTION AND THE CORRECT INSERTION TECHNIQUE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2018-00048.

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-60138 (OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM); BATCH NUMBER: V1382507 AND V1389095. (MFR REPORTS 9680825-2018-00048 RESPECTIVELY); QUANTITY: 1 EACH; HOSPITAL NAME: (B)(6). DATE OF SURGERY: ON (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: OTHER; PATIENT INFORMATION: 12 YEARS, FEMALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SURGERY WAS FOR APPLICATION OF THE TL HEX FIXATOR. DURING APPLICATION OF THE TRUE LOK HEX EXTERNAL FIXATOR DR. (B)(6) PRE DRILLED 3.2 DRILL BIT 1ST SCREW 99-60138 (LOT: V1382507) 1IN CORTISIZED IT BROKE DURING THE DRILLING. THE 2ND BONE SCREW 99-60138 (LOT: V1389095) BROKE ONCE THE SCREW WAS ALL THE WAY THROUGH THE BONE WHILE FASTENING IN IT SNAPPED OUT. INCREASED SURGERY BY 5 MINUTES. ADVERSE EFFECTS ON PATIENT LEFT WITH TWO BROKE SCREWS IN THE TIBIA. THE SURGERY WAS COMPLETED WITH THE DEVICE. NO X-RAYS OR OPERATIVE REPORTS ARE AVAILABLE. CASE TOOK PLACE AT (B)(6) MED. (ACCT: (B)(4) ON (B)(6) 2018. PT.CLC, 12 YR. FEMALE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS); THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: UNK. ON JUNE 6, 2018 ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT TOGETHER WITH SOME X-RAYS: 1. THE PATIENT IS DOING GREAT, 2. THE PATIENT IS 5'2, 150 LBS, 3. THE PARTS WERE SCREWED IN BY HAND. MANUFACTURER REFERENCE NUMBER: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2018-00048.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE 99-60138 LOT V1382507 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(6) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (MFR REPORT 9680825-2018-00047). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE 99-60138 LOT V1389095 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF (B)(6) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT (MFR REPORT 9680825-2018-00048). TECHNICAL EVALUATION. THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICES CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. MEDICAL EVALUATION. THE INFORMATION MADE 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 INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-60138 (OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM); BATCH NUMBER: V1382507 AND V1389095 (MFR REPORTS 9680825-2018-00047 AND 9680825-2018-00048 RESPECTIVELY); QUANTITY: 1 EACH; HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: OTHER; PATIENT INFORMATION: (B)(6) YEARS, FEMALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SURGERY WAS FOR APPLICATION OF THE TL HEX FIXATOR. DURING APPLICATION OF THE TRUE LOK HEX EXTERNAL FIXATOR DR. (B)(6) PRE DRILLED 3.2 DRILL BIT 1ST SCREW 99-60138 (LOT V1382507) 1 IN CORTISIZED IT BROKE DURING THE DRILLING. THE 2ND BONE SCREW 99-60138 (LOT V1389095) BROKE ONCE THE SCREW WAS ALL THE WAY THROUGH THE BONE WHILE FASTENING IN IT SNAPPED OUT. INCREASED SURGERY BY 5 MINUTES. ADVERSE EFFECTS ON PATIENT LEFT WITH TWO BROKE SCREWS IN THE TIBIA. THE SURGERY WAS COMPLETED WITH THE DEVICE. NO X-RAYS OR OPERATIVE REPORTS ARE AVAILABLE. CASE TOOK PLACE AT (B)(6) HOSPITAL MED. (ACCT (B)(4)) ON (B)(6) 2018. PT.CLC, (B)(6) YR. FEMALE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS); THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: UNK. ON (B)(6) 2018 ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT TOGETHER WITH SOME X-RAYS: THE PATIENT IS DOING GREAT; THE PATIENT IS 5'2, (B)(6) LBS; THE PARTS WERE SCREWED IN BY HAND. (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2018-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445389 OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM JDW ORTHOFIX SRL 99-60138 V1382507

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention