OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM
Report
- Report Number
- 9680825-2015-00072
- Event Type
- Injury
- Date Received
- December 2, 2015
- Report Date
- January 8, 2016
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDW
- PMA / PMN Number
- K974186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-60138 BATCH NUMBER G149 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071) THE RETURNED DEVICES, RECEIVED ON NOVEMBER 6TH, 2015 WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL CHECK, WHICH CONFIRMED THE PROBLEM NOTIFIED, AND THEN SENT TO AN EXTERNAL LABORATORY FOR THE CHEMICAL AND FAILURE ANALYSIS. THE RESULTS OF THE TECHNICAL INVESTIGATION EVIDENCED THAT THE CHEMICAL COMPOSITION OF THE RAW MATERIAL OF BOTH BONE SCREWS IS IN CONFORMITY TO ORTHOFIX SRL DESIGN SPECIFICATION. BOTH DEVICES BROKE DUE TO REVERSE BENDING FATIGUE FAILURE. MEDICAL EVALUATION SUMMARY: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. NOVEMBER 18, 2015 "THIS PATIENT IS PROBABLY A YOUNG PATIENT AS I THINK THAT THE EPIPHYSEAL LINE IS STILL OPEN IN THE DISTAL FEMUR. THIS PATIENT WAS HAVING A FEMORAL LENGTHENING. HE HAS A FIXATOR APPLIED (WE ARE NOT TOLD WHAT) AND TOWARDS THE END OF LENGTHENING THE PROXIMAL BONE SCREWS BOTH BROKE. THESE SCREWS HAD A 4.5 - 3.5 MM THREAD, WHEREAS THE DISTAL SCREWS HAVE A 6 - 5 MM THREAD. IN EACH CASE THE SCREWS ARE CLOSE TOGETHER AND POSSIBLY NOT IN THE OUTER SCREW SEATS OF THE CLAMP. IN AN ACTIVE CHILD THIS BREAKAGE WAS ENTIRELY PREDICTABLE WITH THIS CHOICE OF BONE SCREWS: THE PROXIMAL SCREWS WOULD HAVE HAD SIGNIFICANT CYCLIC MOVEMENT TRANSMITTED TO THEM BECAUSE OF THE RELATIVE RIGIDITY OF THE DISTAL SCREWS, AND THIS WOULD HAVE CAUSED FATIGUE FAILURE. TRAGICALLY THE LENGTH GAINED HAS BEEN LOST AND IN ADDITION THERE IS A VARUS DEFORMITY. I FEEL VERY SAD FOR THIS PATIENT; THE SCREW BREAKAGES WERE ENTIRELY DUE TO THE TYPE OF BONE SCREWS CHOSEN. THERE SHOULD HAVE BEEN THREE SCREWS EVENLY SPACED IN EACH CLAMP AND THE SCREWS SHOULD ALL HAVE BEEN THE SAME DIAMETER, IDEALLY WITH 5 - 6 MM THREADS.". DECEMBER 15, 2015 WITH THE RESULT OF THE TECHNICAL EVALUATION "THE EVIDENCE IS CLEAR THAT THESE SCREWS HAD BOTH BEEN SUBJECT TO CYCLIC REVERSE BENDING THAT PRODUCED A GRADUAL FATIGUE FAILURE. IT IS INTERESTING HOW LITTLE OF EACH BONE SCREW REMAINED INTACT JUST BEFORE THE FINAL BREAKAGE. THERE ARE VARIOUS FACTORS, WHICH HAVE COMBINED TO PRODUCE THIS VERY UNUSUAL DOUBLE BONE SCREW FATIGUE FAILURE: 1) THE PROXIMAL BONE SCREWS WERE SMALLER (3.5 - 4.5 MM) THAN THE DISTAL SCREWS (5.0 - 6.0 MM). THE PROXIMAL WOULD THEREFORE BE LESS STIFF THAN THE DISTAL SCREWS. 2) THE WORKING LENGTH OF THE PROXIMAL FRAGMENT IS APPROXIMATELY 50% LONGER THAN THAT OF THE DISTAL FRAGMENT, INCREASING THE LOAD ON THE PROXIMAL FIXATION 3) THE PROXIMAL SCREWS ARE THE SAME DISTANCE APART AS THE DISTAL SCREWS 4) THEREFORE, ALL THE ABOVE PHYSICAL FACTORS ARE COMBINED TO FOCUS THE CYCLIC BENDING LOAD AT THE WEAKEST POINT IN THE SYSTEM, WHERE THE PROXIMAL SCREWS NARROW DOWN FROM 6.0 MM TO 4.5 MM. THIS TECHNICAL ANALYSIS CONFIRMS THAT THE SCREW BREAKAGE HERE WAS ENTIRELY DUE TO THE CHOICE OF IMPLANT AND THE PHYSICAL DISPOSITION OF THE FIXATION. THIS RESULTED IN A FATIGUE LOAD BEING APPLIED TO THESE SCREWS RESULTING IN FATIGUE FAILURE AT THE WEAKEST POINT. THIS COULD HAVE BEEN AVOIDED WITH A DIFFERENT FIXATION CONFIGURATION.". FINAL COMMENTS THE RESULTS OF THE TECHNICAL INVESTIGATION EVIDENCED THAT THE CHEMICAL COMPOSITION OF THE RAW MATERIAL OF BOTH BONE SCREWS IS IN CONFORMITY TO ORTHOFIX SRL DESIGN SPECIFICATION. BOTH DEVICES BROKE DUE TO REVERSE BENDING FATIGUE FAILURE. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "THE SCREW BREAKAGES WERE ENTIRELY DUE TO THE TYPE OF BONE SCREWS CHOSEN. THERE SHOULD HAVE BEEN THREE SCREWS EVENLY SPACED IN EACH CLAMP AND THE SCREWS SHOULD ALL HAVE BEEN THE SAME DIAMETER, IDEALLY WITH 5 - 6 MM THREADS. THE TECHNICAL ANALYSIS CONFIRMS THAT THE SCREW BREAKAGE HERE WAS ENTIRELY DUE TO THE CHOICE OF IMPLANT AND THE PHYSICAL DISPOSITION OF THE FIXATION. THIS RESULTED IN A FATIGUE LOAD BEING APPLIED TO THESE SCREWS RESULTING IN FATIGUE FAILURE AT THE WEAKEST POINT. THIS COULD HAVE BEEN AVOIDED WITH A DIFFERENT FIXATION CONFIGURATION.". PLEASE FIND BELOW AN EXTRACT TAKEN FROM THE ORTHOFIX SRL INSTRUCTION FOR USE, ORTHOFIX® BONE SCREWS FOR EXTERNAL FIXATION SYSTEM, REF: PQ SCR "5) SCREW DIAMETER SHOULD BE SELECTED IN ACCORDANCE WITH BONE DIAMETER. THE MAXIMUM DIAMETER OF THE SCREW THREAD SHOULD NOT BE GREATER THAN ONE THIRD OF THE BONE DIAMETER (E.G. 6-5 OR 6-5.6 MM BONE SCREWS FOR BONE DIAMETER GREATER THAN 20 MM). 21) CARE SHOULD BE TAKEN DURING USAGE OF THREAD DIAMETER 4.5-3.5 MM BONE SCREWS WITH A LONG SHAFT, SINCE THE RISK OF FATIGUE OR OTHER FAILURE MAY BE SLIGHTLY HIGHER THAN WITH OUR STANDARD SCREW RANGE. PARTICULAR CARE SHOULD BE TAKEN DURING SCREW INSERTION IF THE BONE IS HARD. ORTHOFIX SUGGESTS USING THREE SCREWS RATHER THAN TWO TO SPREAD THE LOAD. IF THE PATIENT IS HEAVY, WEIGHTBEARING SHOULD BE LIMITED.". ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS DATE OF INITIAL SURGERY AND TYPE OF FIXATOR APPLIED, PATIENT INFORMATION (AGE, SEX AND WEIGHT), DATE OF THE BONE SCREWS BREAKAGE, PATIENT DIAGNOSIS AND PROPOSED TREATMENT, DATE OF THE ADDITIONAL SURGERY AND TYPE OF FIXATOR AND BONE SCREWS APPLIED, COPIES OF THE OPERATIVE REPORTS, COPIES OF THE PRE AND POST-OPERATIVE X-RAYS (BETTER QUALITY X-RAYS INCLUDING AFTER SECOND SURGERY), CURRENT SITUATION IN REGARDS TO THE PLANNED GOAL, CLARIFICATION ON THE DATE OF THE SURGEON NOTIFICATION (AS SPECIFIED IN THE NOTE SECTION OF THE COMPLAINT FORM). UNFORTUNATELY THIS INFORMATION HAS NOT BEEN MADE AVAILABLE. SHOULD FURTHER INFORMATION BECOMES AVAILABLE, ORTHOFIX SRL WILL PROMPTLY RE-OPEN THE INVESTIGATION. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE LOT. ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF 740 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE CODE. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICES, RECEIVED ON (B)(4) 2015, IS CURRENTLY ON GOING (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071). 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. ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS DATE OF INITIAL SURGERY AND TYPE OF FIXATOR APPLIED, PATIENT INFORMATION (AGE, SEX AND WEIGHT), DATE OF BONE SCREWS BREAKAGE, PATIENT DIAGNOSIS AND PROPOSED TREATMENT, DATE OF THE ADDITIONAL SURGERY AND TYPE OF FIXATOR AND BONE SCREWS APPLIED, COPIES OF THE OPERATIVE REPORTS, COPIES OF THE PRE AND POST OPERATIVE X-RAYS (BETTER QUALITY X-RAYS INCLUDING AFTER SECOND SURGERY), CURRENT SITUATION IN REGARDS TO THE PLANNED GOAL, CLARIFICATION ON THE DATE OF THE SURGEON NOTIFICATION (AS SPECIFIED IN THE NOTE SECTION OF THE COMPLAINT FORM). UNFORTUNATELY THIS INFORMATION HAS NOT BEEN MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION, CURRENTLY ON GOING, ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: O PRODUCT CODE: 99-60138, O BATCH NUMBER: G149, O QUANTITY: 2 (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071). O HOSPITAL NAME: (B)(6). O SURGEON NAME: DR. (B)(6). O DATE OF SURGERY: NOT PROVIDED. O BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR. O SURGERY DESCRIPTION: LENGTHENING. O PATIENT INFORMATION: NOT PROVIDED. O PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. O TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. O EVENT DESCRIPTION: THE PROXIMAL SCREWS BROKE DURING THE END (TIME) OF THE TREATMENT. USE ONLY 2 SCREW FOR EACH CLAMP WITH TWO DIFFERENT SIZES. PROXIMAL CLAMP WITH A 3,5-4,5 DIAMETER SCREW. DISTAL CLAMP WITH A 5-6 DIAMETER SCREW. THE TWO PROXIMAL SCREW BROKE BOTH AT THE END OF THE TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF DISTRACTION/CORRECTION ACHIEVED). - THE INITIAL 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 REQUIRED FOLLOWING DEVICE FAILURE. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAYS ARE AVAILABLE. - PATIENT CURRENT HEALTH CONDITION: GOOD. - NOTE AND COMMENTS: "THE ATTACHED XRAY IS DATED (B)(6) 2015 - THE EVENT WAS NOTIFIED BY THE SURGEON AT THE (B)(6) 2015". ORTHOFIX SRL WAS INFORMED OF THIS EVENT ON NOV 5, 2015 AND IS CURRENTLY INVESTIGATING ON THE NOTE REGARDING THE SURGEON NOTIFICATION. NO FURTHER INFORMATION N HAS BEEN MADE AVAILABLE. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-60138; BATCH NUMBER: G149; QUANTITY: 2 (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071); HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: NOT PROVIDED; BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR; SURGERY DESCRIPTION: LENGTHENING; PATIENT INFORMATION: NOT PROVIDED; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE PROXIMAL SCREWS BROKE DURING THE END (TIME) OF THE TREATMENT. USE ONLY 2 SCREW FOR EACH CLAMP WITH TWO DIFFERENT SIZES. PROXIMAL CLAMP WITH A 3,5-4,5 DIAMETER SCREW. DISTAL CLAMP WITH A 5-6 DIAMETER SCREW. THE TWO PROXIMAL SCREW BROKE BOTH AT THE END OF THE TREATMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF DISTRACTION/CORRECTION ACHIEVED); THE INITIAL 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 REQUIRED FOLLOWING DEVICE FAILURE; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAYS ARE AVAILABLE; PATIENT CURRENT HEALTH CONDITION: GOOD. NOTE AND COMMENTS: "THE ATTACHED XRAY IS DATED (B)(6) 2015 - THE EVENT WAS NOTIFIED BY THE SURGEON AT THE (B)(6) 2015". ORTHOFIX SRL WAS INFORMED OF THIS EVENT ON (B)(6) 2015 AND IS CURRENTLY INVESTIGATING ON THE NOTE REGARDING THE SURGEON NOTIFICATION. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2015-00071. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791889 | 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 | G149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |