MODULAR 5/8 RING, 200MM, TL-HEX
Report
- Report Number
- 9680825-2017-00005
- Event Type
- Malfunction
- Date Received
- February 9, 2017
- Date of Event
- January 12, 2017
- Report Date
- March 17, 2017
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K152171
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE RING CODE 56-21460, LOT V1420385 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, 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 NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE TECHNICAL EVALUATION OF THE DEVICE INVOLVED, RECEIVED ON FEBRUARY 1, 2017, IS CURRENTLY ON GOING. 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 INVESTIGATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. DEVICE EVALUATION CURRENTLY ON GOING.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE RING CODE 56-21460 LOT V1420385 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF 10 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. TECHNICAL EVALUATION THE RETURNED DEVICE, RECEIVED ON FEBRUARY 1, 2017 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED, THE 5/8 RING IS BROKEN. THE DIMENSIONAL CHECK OF THE BROKEN RING, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. A FUNCTIONAL CHECK ON THE RETURNED DEVICE WAS NOT POSSIBLE AS THE DEVICE IS BROKEN AND THEREFORE NOT FUNCTIONING. THE DEVICE WAS 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 DEVICE CONFORMITY TO DESIGN SPECIFICATION. THE RING BROKE DUE TO STRESS CORROSION (COMBINATION OF OXIDATION AND FATIGUE STRESS). 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 EVALUATIONS PERFORMED. ON JANUARY 27, 2017: "IN THIS CASE A MIDDLE AGED PATIENT HAD A TL-HEX FRAME IN PLACE FROM (B)(6) 2016 TO (B)(6) 2017. THIS IS NOT SO LONG FOR A RECONSTRUCTION OPERATION. THE PATIENT WAS FULLY WEIGHTBEARING AND NOTICED A BREAK IN THE RING JUST BEFORE IT WAS DUE TO BE REMOVED. THE WHOLE FRAME WAS REMOVED AS PLANNED AND THE TREATMENT WAS COMPLETED AS PLANNED. IT WOULD BE USEFUL TO KNOW THE TREATMENT BEING CARRIED OUT AND THE DESIGN OF THE FRAME. AN AVERAGE ADULT MALE CAN PUT A LOT OF LOAD THROUGH A RING DURING FULL WEIGHTBEARING, BUT THIS IS WHAT THEY ARE DESIGNED FOR". ON FEBRUARY 8, 2017: "WE NOW KNOW THAT THIS PATIENT WAS BEING TREATED FOR A FRACTURE, SO THE TIME FRAME OF TREATMENT IS UNDERSTANDABLE. THE FRAME CONSISTED OF TWO PAIRS OF 200 MM RINGS, WITH THE DISTAL ONE BEING A 200 MM DOUBLE ROW FOOT PLATE. SIX TL-HEX STRUTS JOINED THE TWO PAIRS OF RINGS AND WERE PRESUMABLY USED TO CORRECT ANY POSITION DISCREPANCY. THE RING WAS ABOUT TO BE REMOVED BECAUSE TREATMENT HAD FINISHED, AND THE PATIENT PRESENTED WITH A BREAK IN THE PROXIMAL RING OF THE DISTAL PAIR. THE PATIENT WAS BY THIS TIME FULLY WEIGHT BEARING, AND THE RING FOR SOME REASON MUST HAVE BEEN SUBJECTED TO FORCES BEYOND THE DESIGN CRITERIA. THE REASONS FOR THIS ARE NOT CLEAR, BUT WILL BE RELATED TO THE FRAME DESIGN. AS STATED BEFORE, TREATMENT WAS SUCCESSFUL. IF THE FRACTURE HEALED QUICKLY IT WOULD HAVE BEEN POSSIBLE TO PUT VERY LARGE LOADS THROUGH A FRAME, BECAUSE EVEN IF THE BONE HAS HEALED THERE MAY BE LARGE BENDING LOADS TRANSMITTED THROUGH AN ATTACHED FRAME". ON MARCH 11, 2017: "I NOTE THAT THIS RING DID INDEED FAIL BECAUSE OF FATIGUE AS WE SUSPECTED. IN THIS CASE THE INVESTIGATIONS HAVE SHOWN TRACES OF CORROSION ON THE SURFACE WHICH MAY WELL HAVE PREDISPOSED THE ITEM TO FATIGUE FAILURE. I NOTE THAT THE CLEANING MATERIAL THAT WAS BEING USED IS CALLED PROGENICA ULTRA CONCENTRATED ALKALINE DETERGENT". ON MARCH 16, 2017: THE DATA SHEET OF THE DETERGENT USED CONFIRMS THAT THE WORKING PH OF THIS CLEANING FLUID IS 9 TO 11. THIS IS WELL ABOVE THE MAXIMUM PERMITTED FOR USE WITH ALUMINIUM INSTRUMENTS AS STATED IN PQ TLK. THIS CONFIRMS THAT THE RING WAS NOT PROCESSED CORRECTLY AND AS A RESULT DEVELOPED CORROSION CHANGES WHICH PREDISPOSED THE RING TO DEVELOP FATIGUE FAILURE. FINAL CONCLUSION: INCORRECT PROCESSING LEADING TO CORROSION CHANGES". FINAL COMMENTS: FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONFIRMED THE DEVICE CONFORMITY TO DESIGN SPECIFICATION. THE RING BROKE DUE TO STRESS CORROSION (COMBINATION OF OXIDATION AND FATIGUE STRESS). THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: ON JANUARY 27, 2017: "IN THIS CASE A MIDDLE AGED PATIENT HAD A TL-HEX FRAME IN PLACE FROM (B)(6) 2016 TO (B)(6) 2017. THIS IS NOT SO LONG FOR A RECONSTRUCTION OPERATION. THE PATIENT WAS FULLY WEIGHTBEARING AND NOTICED A BREAK IN THE RING JUST BEFORE IT WAS DUE TO BE REMOVED. THE WHOLE FRAME WAS REMOVED AS PLANNED AND THE TREATMENT WAS COMPLETED AS PLANNED. IT WOULD BE USEFUL TO KNOW THE TREATMENT BEING CARRIED OUT AND THE DESIGN OF THE FRAME. AN AVERAGE ADULT MALE CAN PUT A LOT OF LOAD THROUGH A RING DURING FULL WEIGHTBEARING, BUT THIS IS WHAT THEY ARE DESIGNED FOR". ON FEBRUARY 8, 2017: "WE NOW KNOW THAT THIS PATIENT WAS BEING TREATED FOR A FRACTURE, SO THE TIME FRAME OF TREATMENT IS UNDERSTANDABLE. THE FRAME CONSISTED OF TWO PAIRS OF 200 MM RINGS, WITH THE DISTAL ONE BEING A 200 MM DOUBLE ROW FOOT PLATE. SIX TL-HEX STRUTS JOINED THE TWO PAIRS OF RINGS AND WERE PRESUMABLY USED TO CORRECT ANY POSITION DISCREPANCY. THE RING WAS ABOUT TO BE REMOVED BECAUSE TREATMENT HAD FINISHED, AND THE PATIENT PRESENTED WITH A BREAK IN THE PROXIMAL RING OF THE DISTAL PAIR. THE PATIENT WAS BY THIS TIME FULLY WEIGHT BEARING, AND THE RING FOR SOME REASON MUST HAVE BEEN SUBJECTED TO FORCES BEYOND THE DESIGN CRITERIA. THE REASONS FOR THIS ARE NOT CLEAR, BUT WILL BE RELATED TO THE FRAME DESIGN. AS STATED BEFORE, TREATMENT WAS SUCCESSFUL. IF THE FRACTURE HEALED QUICKLY IT WOULD HAVE BEEN POSSIBLE TO PUT VERY LARGE LOADS THROUGH A FRAME, BECAUSE EVEN IF THE BONE HAS HEALED THERE MAY BE LARGE BENDING LOADS TRANSMITTED THROUGH AN ATTACHED FRAME". ON MARCH 11, 2017: "I NOTE THAT THIS RING DID INDEED FAIL BECAUSE OF FATIGUE AS WE SUSPECTED. IN THIS CASE THE INVESTIGATIONS HAVE SHOWN TRACES OF CORROSION ON THE SURFACE WHICH MAY WELL HAVE PREDISPOSED THE ITEM TO FATIGUE FAILURE. I NOTE THAT THE CLEANING MATERIAL THAT WAS BEING USED IS CALLED PROGENICA ULTRA CONCENTRATED ALKALINE DETERGENT". ON MARCH 16, 2017: THE DATA SHEET OF THE DETERGENT USED CONFIRMS THAT THE WORKING PH OF THIS CLEANING FLUID IS 9 TO THIS IS WELL ABOVE THE MAXIMUM PERMITTED FOR USE WITH ALUMINIUM INSTRUMENTS AS STATED IN PQ TLK. THIS CONFIRMS THAT THE RING WAS NOT PROCESSED CORRECTLY AND AS A RESULT DEVELOPED CORROSION CHANGES WHICH PREDISPOSED THE RING TO DEVELOP FATIGUE FAILURE. FINAL CONCLUSION: INCORRECT PROCESSING LEADING TO CORROSION CHANGES". BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS MAINLY DUE TO THE USE OF A CLEANING SOLUTION (PROGENICA ULTRA CONCENTRATED ALKALINE DETERGENT), CONTRAINDICATED IN THE ORTHOFIX (B)(4) INSTRUCTIONS FOR USE LEAFLET, REF: PQ TLK, LEADING TO CORROSION CHANGES WHICH PREDISPOSED THE RING TO DEVELOP FATIGUE FAILURE. ORTHOFIX WOULD LIKE TO REMIND THAT THE INSTRUCTIONS FOR THE SAFE PROCESSING OF THE ORTHOFIX (B)(4) DEVICES ARE INCLUDED IN THE INSTRUCTIONS FOR USE LEAFLET, REF: PQ TLK. 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.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: MIDDLE AGE MALE; PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE FATIGUED RING WAS IDENTIFIED IN CLINIC ON 12TH JANUARY BUT THE FRAME WAS READY FOR REMOVAL AND WAS THEREFORE SCHEDULED TO BE REMOVED THE FOLLOWING DAY. PATIENT TOLD THE CONSULTANT IT JUST SUDDENLY OCCURRED AND HE WAS NOT CARRYING OUT ANYTHING PARTICULAR STRENUOUS. THE PATIENT WAS WEIGHT BEARING WITH THE USE OF A COMPETITOR WALKER RAIL ATTACHED, ALSO BELIEVED TO HAVE BEEN BROKEN IN SOME WAY". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; NO CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED (REQUIRED TO BE REMOVED ANYWAY); A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE; INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS. ON (B)(6) 2017, ORTHOFIX (B)(4) RECEIVE THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: IT WAS USED FOR TRAUMA, FRACTURE TREATMENT; THE DESIGN OF THE FRAME WAS AS PER THE IMAGE, HOWEVER TAKEN OFF BEFORE THE IMAGE WERE 6 LONG TL HEX STRUTS BETWEEN THE TWO RING BLOCKS. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: MR (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: MIDDLE AGE MALE; PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE FATIGUED RING WAS IDENTIFIED IN CLINIC ON (B)(6) BUT THE FRAME WAS READY FOR REMOVAL AND WAS THEREFORE SCHEDULED TO BE REMOVED THE FOLLOWING DAY. PATIENT TOLD THE CONSULTANT IT JUST SUDDENLY OCCURRED AND HE WAS NOT CARRYING OUT ANYTHING PARTICULAR STRENUOUS. THE PATIENT WAS WEIGHT BEARING WITH THE USE OF A COMPETITOR WALKER RAIL ATTACHED, ALSO BELIEVED TO HAVE BEEN BROKEN IN SOME WAY". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; NO CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED (REQUIRED TO BE REMOVED ANYWAY); A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE (BUT FRAME IMAGES ATTACHED); INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS. ON FEBRUARY 6, 2017, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: - IT WAS USED FOR TRAUMA, FRACTURE TREATMENT. - THE DESIGN OF THE FRAME WAS AS PER THE IMAGE, HOWEVER TAKEN OFF BEFORE THE IMAGE WERE 6 LONG TL HEX STRUTS BETWEEN THE TWO RING BLOCKS. ON MARCH 8, 2017, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: "THE DETERGENT USED DURING THE DECONTAMINATION ACTIVITIES IS PROGENICA ULTRA CONCENTRATED ALKALINE DETERGENT" (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98194 | MODULAR 5/8 RING, 200MM, TL-HEX | MODULAR 5/8 RING, 200MM, TL-HEX | KTT | ORTHOFIX SRL | 56-21460 | V1420385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |