TRUE LOK WIRE
Report
- Report Number
- 9680825-2016-00100
- Event Type
- Injury
- Date Received
- November 23, 2016
- Report Date
- January 27, 2017
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K152171
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099) TL+ FOOT PLATE EXTENSION 5 HOLE: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 56-14590 LOT 1506390 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 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 DEVICE CODE 56-14590 LOT 1508633 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 SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT (RAPID STRUT): ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10180 LOT V1423367 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. (B)(4) 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 DEVICE CODE 50-10180 LOT V1418051 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 SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TL WIRE: THE BROKEN WIRE WAS DISPOSED OF BY THE HOSPITAL. UNFORTUNATELY ALSO THE CODE AND THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099) THE RETURNED DEVICES, RECEIVED ON NOVEMBER 24, 2016 (THE TWO STRUTS CODE 50-10180) AND ON DECEMBER 12, 2016 (THE TWO FOOT PLATE EXTENSION CODE 56-14590), WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE RETURNED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. 1) FOOT PLATE EXTENSION CODE 56-14590 BATCH 1506390: THE VISUAL CHECK CONFIRMED THAT THE DEVICE IS CRACKED IN CORRESPONDENCE OF THE EDGE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK, PERFORMED WHERE POSSIBLE AS THE DEVICE IS CRACKED, EVIDENCED THAT THE DEVICE IS FUNCTIONING PROPERLY EXCEPT FROM THE BROKEN PART. 2) FOOT PLATE EXTENSION CODE 56-14590 BATCH 1508633: THE VISUAL CHECK CONFIRMED THAT THE DEVICE IS BROKEN IN CORRESPONDENCE OF THE HOLE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK, PERFORMED WHERE POSSIBLE AS THE DEVICE IS BROKEN, EVIDENCED THAT THE DEVICE IS FUNCTIONING PROPERLY EXCEPT FROM THE BROKEN PART. 3) QUICK ADJUST STRUT CODE 50-10180 BATCH V1423367: THE VISUAL CHECK EVIDENCED THAT ONE THREADED ROD OF THE DEVICE IS BROKEN DUE TO A BENDING/FLEXURAL OVERLOAD. ALSO THE COMPONENT CODE 50-10180-1 (MEDIUM ROD AND SOCKET) EVIDENCED SIGNS OF DAMAGING. THE THREADED ROD WAS CHECKED USING THE GO GAUGE AND THE PROJECTOR PROFILE AND FOUND TO BE IN CONFORMITY WITH THE SPECIFICATION. THE FUNCTIONAL CHECK, PERFORMED WHERE POSSIBLE AS THE DEVICE IS BROKEN, EVIDENCED THAT THE DEVICE IS FUNCTIONING PROPERLY EXCEPT FROM THE BROKEN PART. 4) QUICK ADJUST STRUT CODE 50-10180 BATCH V1418051: THE VISUAL CHECK EVIDENCED THAT ONE THREADED ROD OF THE DEVICE IS BROKEN DUE TO A BENDING/FLEXURAL OVERLOAD. ALSO THE COMPONENT CODE 50-10170-8 (PLASTIC DRIVE BUSHING) EVIDENCED SIGNS OF DAMAGING. IT WAS NOT POSSIBLE TO PERFORM ANY CHECKS ON THE THREADED ROD AS IT IS DAMAGED. 5) TL WIRE CODE AND BATCH UNKNOWN: A TECHNICAL EVALUATION OF THE BROKEN WIRE WAS NOT POSSIBLE AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. _____________________________________________________________________________________ THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1.) FOOT PLATE EXTENSION; BOTH DEVICES CRACK OR BROKE NEXT TO THE HOLE. FROM THE ANALYSIS OF THE SURFACE'S BREAKAGE, IT WAS ASSUMED THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD. 2.) QUICK ADJUST STRUT; THE THREADED ROD OF BOTH DEVICES BROKE AT THE BEGINNING OF ITS LENGTH. FROM THE ANALYSIS OF THE SURFACE'S BREAKAGE, IT WAS ASSUMED THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD RELATED TO THIS SPECIFIC APPLICATION (THE CONNECTION BAR IS ALMOST HORIZONTAL). TO AVOID THIS KIND OF BREAKAGE, THE STRUT SHOULD BE POSITIONED IN AXIS WITH THE FRAME TO WHICH IT IS APPLIED. IN THIS SPECIFIC CASE, A POST COULD HAVE BEEN USED TO CONNECT THE STRUT TO THE RING. 3.) BROKEN WIRE; A TECHNICAL EVALUATION OF THE BROKEN WIRE WAS NOT POSSIBLE AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099) THE INFORMATION MADE AVAILABLE ON THE EVENT OVER THE TIME TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. OCTOBER 6, 2016 "HERE WE HAVE A FRAME WITH A FOOT PLATE, SINGLE ROW, DIAMETER NOT DEFINED, BEING USED WITH 2 X 5 HOLE EXTENSION PLATES. THE CYCLIC LOADING OF THE FRAME HAS PRODUCED FATIGUE CRACKS PROPAGATING FROM THE CORNER OF THE JOINT IN EACH CASE, ONE MORE MARKED THAN THE OTHER. I IMAGINE THAT THE LOAD CAUSED BY WEIGHTBEARING WILL HAVE PRODUCED CYCLIC BENDING AT THESE JOINTS WHICH HAS CAUSED THE PROBLEM. IT IS LIKELY THAT THERE WAS NO CROSS-BRACING OF THE EXTENSION PLATES WHICH WOULD HAVE CAUSED THE BENDING LOAD TO BE CONCENTRATED AT THE JOINTS. I THINK THAT THIS PART OF THE FRAME WAS SUBJECT TO CYCLIC LOADING BEYOND THE DESIGN CRITERIA, WHICH CAUSED THE FATIGUE FAILURE". NOVEMBER 11, 2016 "WE CAN NOW SEE THE WHOLE FRAME AND PERCEIVE THAT IT IS QUITE COMPLEX. THERE ARE 4 RINGS FROM PROXIMAL TIBIA TO THE FOOT. THE PROXIMAL RING (NO. 1) HAS ONE TRANSVERSE TENSIONED WIRE AND TWO BONE SCREWS; THE SECOND RING (NO. 2) HAS TWO ANTERIOR BONE SCREWS. THESE TWO RINGS ARE JOINED BY 6 STRUTS IN A STANDARD TL-HEX FRAME, DESIRING TO ACHIEVE A PROXIMAL TIBIAL CORRECTION. SO THE PROXIMAL PAIR OF RINGS IS ACTING AS AN INDEPENDENT FRAME. THE 3RD RING (NO. 3) IS ATTACHED TO RING NO. 2 BY THREE THREADED BARS, AND IS OVER THE DISTAL TIBIA AND ATTACHED TO IT BY ONE ANTERIOR BONE SCREW. (HOWEVER, RINGS 2 AND 3 ACT AS A RIGID BLOCK, SO IN EFFECT THEY ARE BOTH ATTACHED TO THE TIBIA BY THREE BONE SCREWS). THE DISTAL RING (NO. 4) CONSISTS OF THE FOOT PLATE WITH AN EXTENSION PLATE ON EACH END, AND WITH AN ARCH JOINING THE ENDS OF THE EXTENSION PLATES OVER THE TOP OF THE FOOT. THE JOINT BETWEEN THE EXTENSION PLATE AND THE FOOT PLATE ON EACH SIDE HAS BEEN REINFORCED BY TWO POSTS WITH A THREADED BAR PARALLEL TO THE FOOTPLATE. THIS WAS PROBABLY ADDED AFTER A CRACK APPEARED IN ONE OF THESE FLANGES. AS FAR AS I CAN SEE THERE ARE THREE TENSIONED WIRES ACROSS THE HIND FOOT FROM THE FOOTPLATE. THE ANTERIOR PART OF THE 4TH RING, CONSISTING OF THE ARCH AND EXTENSION PLATES, IS NOT ATTACHED TO THE FOOT BY SCREWS OR WIRES. THERE ARE 4 QUICK ADJUST STRUTS BETWEEN RINGS 3 AND 4; TWO ARE BETWEEN RING 3 AND THE FOOTPLATE OF RING 4, AND TWO ARE BETWEEN RING 3 AND THE ANTERIOR ARCH OF RING 4. IN ADDITION THE FOOT PLATE IS HOLDING A FOOT SUPPORT WHICH IS ATTACHED BY FOUR THREADED RODS. SO, THE FRAME CONSISTS OF TWO RING BLOCKS OF TWO RINGS EACH, WHICH ARE JOINED AT MID-TIBIAL LEVEL BY THREE THREADED RODS. PROXIMAL CORRECTION WILL HAVE BEEN WITH COMPUTER PROGRAMME GUIDANCE AND SEEMS TO HAVE BEEN VERY SATISFACTORY. DISTAL CORRECTION LOOKS QUITE GOOD IN THE FINAL IMAGES, BUT CANNOT BE WITH COMPUTER CONTROL AND I HAVE ALWAYS THOUGH THAT IT IS VERY DIFFICULT TO KEEP THE LOAD BEING TRANSMITTED BY FOUR STRUTS ROUGHLY EQUAL: IT IS CAN EASILY HAPPEN THAT THE LOAD BEING CARRIED BY ONE OF THE STRUTS BECOMES GREATER THAN THE OTHERS AS CORRECTION PROCEEDS. IN THIS FRAME WE SEE THAT THE THREADED BARS AT THE PROXIMAL ENDS OF THE TWO POSTERIOR STRUTS IN THE DISTAL BLOCK HAVE BROKEN, AS HAS ONE OF THE TENSIONED HIND FOOT WIRES. IN THIS FRAME THE ANTERIOR PART OF THE FOOT RING COMPLEX WAS SUBJECT TO CYCLIC MOVEMENT ON WEIGHTBEARING ABOUT THE AXIS BETWEEN THE EXTENSION PLATE / FOOT PLATE JOINTS; WHEN THESE WERE REINFORCED THE FOCUS MOVED POSTERIORLY TO THE PROXIMAL ENDS OF THE TWO POSTERIOR QUICK ADJUST STRUTS. SO THERE WAS A CASCADE OF FATIGUE FAILURE PROVOKED BY THE RELATIVE ELASTICITY OF THE FOOT COMPONENT OF THE FRAME. THIS IS A COMPLEX FRAME AND GENERALLY, THE RESULTS OF TREATMENT SEEM TO HAVE BEEN VERY SATISFACTORY. THESE BREAKAGES MIGHT HAVE BEEN AVOIDED IF THE FRAME DESIGN SUGGESTED IN THE OPERATIVE TECHNIQUE, REF. TL-0922 HAD BEEN FOLLOWED MORE CLOSELY; ON PAGE 11, FIG. 12 THE DIAGRAM SHOWS ANTERIOR CONNECTION BETWEEN THE TIBIAL RING AND THE FOOT PLATE CLOSER TO THE EXTENSION PLATES, RATHER THAN VIA THE FOOT ARCH AS IN THIS CASE. THIS COULD HAVE BEEN DONE IN THIS CASE WITH THE QUICK ADJUST STRUTS, WITH A SEPARATE CONNECTION BETWEEN THE DISTAL TIBIAL RING AND THE FOOT ARCH AS IN FIG. 10, PAGE 10. IT IS VERY EASY TO BE WISE AFTERWARDS, BUT I THINK THAT THE PROBLEM HERE WAS RELATIVELY ELASTIC SUPPORT OF THE HIND FOOT IN AN OTHERWISE QUITE RIGID FRAME, WHICH CREATED EXCESSIVE CYCLIC LOADING AND BENDING AT THE EXTENSION PLATE / FOOT PLATE CONNECTIONS ORIGINALLY, AND THEN AT THE POSTERIOR ASPECT OF THE HIND FOOT FRAME. SO, IN MY VIEW THESE BREAKAGES, WHICH WILL ALL BE FATIGUE FAILURES, WERE DUE TO THE PARTICULAR PHYSICAL CHARACTERISTICS OF THIS FRAME, WHICH RESULTED IN LOADING OF THESE COMPONENTS BEYOND THEIR DESIGN CRITERIA". JANUARY 21, 2017 WITH THE RESULTS OF THE TECHNICAL EVALUATION "THE TECHNICAL EVALUATION MAKES IT CLEAR THAT THE BROKEN COMPONENTS IN THIS CASE WERE SUBJECTED TO HIGH LOAD FLEXURAL BENDING RESULTING IN EARLY FATIGUE FAILURE FOLLOWED BY FINAL BREAKAGE. AS ALREADY SUGGESTED, THIS WAS DUE TO PARTICULAR FEATURES OF THE DESIGN OF THIS FRAME WHICH RESULTED IN EXCESSIVE LOAD BEING CONCENTRATED ON A FEW COMPONENTS. MAY I SUGGEST THAT THE REPORT EMPHASISES THAT THIS WAS A PROCESS OF FATIGUE FAILURE WHICH PRODUCE A CRACK AT THE POINT OF FAILURE IN EACH CASE FOLLOWED BY SUCCESSIVE WEAKENING AS THE CRACK EXTENDED FOLLOWED BY FINAL FAILURE. I NOTE THAT THE ORIGINAL SURGERY WAS IN NOVEMBER/DECEMBER 2015, EXACT DATE UNCERTAIN. I THINK THAT WHAT HAPPENED HERE WAS THAT THE ORIGINAL FRACTURE(S) HAD BY THIS TIME HEALED, AND THIS RESULTED IN THE POSSIBILITY OF THE PATIENT TRANSMITTING GREATER LOADS TO THE FRAME. PERHAPS THE FRAME SHOULD HAVE BEEN REMOVED EARLIER?. THE RESULT OF THE TECHNICAL EVALUATION CONFIRMS OUR ORIGINAL THOUGHTS ABOUT THE MECHANISM OF FAILURE IN THIS CASE". FINAL COMMENTS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099) THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1.) FOOT PLATE EXTENSION; BOTH DEVICES CRACK OR BROKE NEXT TO THE HOLE. FROM THE ANALYSIS OF THE SURFACE'S BREAKAGE, IT WAS ASSUMED THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD. 2.) QUICK ADJUST STRUT; THE THREADED ROD OF BOTH DEVICES BROKE AT THE BEGINNING OF ITS LENGTH. FROM THE ANALYSIS OF THE SURFACE'S BREAKAGE, IT WAS ASSUMED THAT THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD RELATED TO THIS SPECIFIC APPLICATION (THE CONNECTION BAR IS ALMOST HORIZONTAL). TO AVOID THIS KIND OF BREAKAGE, THE STRUT SHOULD BE POSITIONED IN AXIS WITH THE FRAME TO WHICH IT IS APPLIED. IN THIS SPECIFIC CASE, A POST COULD HAVE BEEN USED TO CONNECT THE STRUT TO THE RING. 3.) BROKEN WIRE; A TECHNICAL EVALUATION OF THE BROKEN WIRE WAS NOT POSSIBLE AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "THE TECHNICAL EVALUATION MAKES IT CLEAR THAT THE BROKEN COMPONENTS IN THIS CASE WERE SUBJECTED TO HIGH LOAD FLEXURAL BENDING RESULTING IN EARLY FATIGUE FAILURE FOLLOWED BY FINAL BREAKAGE. AS ALREADY SUGGESTED, THIS WAS DUE TO PARTICULAR FEATURES OF THE DESIGN OF THIS FRAME WHICH RESULTED IN EXCESSIVE LOAD BEING CONCENTRATED ON A FEW COMPONENTS. THE REPORT EMPHASISES THAT THIS WAS A PROCESS OF FATIGUE FAILURE WHICH PRODUCE A CRACK AT THE POINT OF FAILURE IN EACH CASE FOLLOWED BY SUCCESSIVE WEAKENING AS THE CRACK EXTENDED FOLLOWED BY FINAL FAILURE. I NOTE THAT THE ORIGINAL SURGERY WAS IN NOVEMBER/DECEMBER 2015, EXACT DATE UNCERTAIN. I THINK THAT WHAT HAPPENED HERE WAS THAT THE ORIGINAL FRACTURE(S) HAD BY THIS TIME HEALED, AND THIS RESULTED IN THE POSSIBILITY OF THE PATIENT TRANSMITTING GREATER LOADS TO THE FRAME. PERHAPS THE FRAME SHOULD HAVE BEEN REMOVED EARLIER? THE RESULT OF THE TECHNICAL EVALUATION CONFIRMS OUR ORIGINAL THOUGHTS ABOUT THE MECHANISM OF FAILURE IN 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 X-RAY IMAGES. BASED ON THE RESULTS OF THE TECHNICAL INVESTIGATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS MAINLY DUE TO THE APPLICATION OF EXCESSIVE FLEXURAL LOAD RELATED TO THIS SPECIFIC APPLICATION. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099). TL+ FOOT PLATE EXTENSION 5 HOLE: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 56-14590 LOT 1506390 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, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 56-14590 LOT 1508633 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, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10180 LOT V1423647 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. (B)(4) 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. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10180 LOT V1418051 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. TL WIRE: THE BROKEN WIRE WAS DISPOSED OF BY THE HOSPITAL. UNFORTUNATELY, ALSO THE CODE AND THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099) THE TECHNICAL EVALUATION ON THE RETURNED STRUTS AND FOOT PLATE EXTENSIONS IS CURRENTLY ON GOING. A TECHNICAL EVALUATION OF THE BROKEN WIRE WAS NOT POSSIBLE AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099). 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 INVESTIGATION, CURRENTLY ON GOING, 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. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099. DEVICE DISPOSED OF BY THE HOSPITAL.
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099). TL+ FOOT PLATE EXTENSION 5 HOLE: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 56-14590 LOT 1506390 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, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 56-14590 LOT 1508633 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, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TRUE LOK PLUS QUICK ADJUST STRUT (RAPID STRUTS): THESE DEVICES HAVE NOT YET BEEN RETURNED. UNFORTUNATELY ALSO THE CODE AND THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TL WIRE: THE BROKEN WIRE WAS DISPOSED OF BY THE HOSPITAL. UNFORTUNATELY ALSO THE CODE AND THE BATCH NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099). A TECHNICAL EVALUATION OF THE TWO FOOT PLATE EXTENSIONS WAS NOT POSSIBLE AS THE FRAME IS STILL IN USE BY PATIENT. A TECHNICAL EVALUATION OF THE TWO STRUTS, RECENTLY FOUND BROKEN, WAS NOT POSSIBLE AS THEY HAVE NOT YET BEEN RECEIVED. A TECHNICAL EVALUATION OF THE BROKEN WIRE WAS NOT POSSIBLE AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL. ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR FOR THE RETURN OF THE TWO STRUTS. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099). 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 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. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00090, 9680825-2016-00092, 9680825-2016-00098 AND 9680825-2016-00099. DEVICE DISPOSED OF BY THE HOSPITAL
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: O PRODUCT CODE: NOT PROVIDED O BATCH NUMBER: NOT PROVIDED O QUANTITY: 1 O HOSPITAL NAME: (B)(6). O SURGEON NAME: MR (B)(6) O DATE OF SURGERY: UNKNOWN, DATE REPORTED: (B)(6) 2016 O BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/FOOT O SURGERY DESCRIPTION: FRACTURE TREATMENT O PATIENT INFORMATION: MALE O PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE O TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM O EVENT DESCRIPTION: FATIGUE OF THE JOINT OF THE FOOT PLATE AND FOOT PLATE EXTENSION PLATES, 1 SIDE SHOWS EARLY SIGNS OF FATIGUE (HAIR LINE CRACK) AND THE OTHER MORE OBVIOUS SIGNS OF FATIGUE (PLEASE SEE IMAGE - FRAME REMAINS ON THE PATIENT). ADVICE GIVEN TO SURGEON AS TO BRIDGE THE AREA OF FATIGUE TO PREVENT FAILURE. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT (ALTHOUGH DEVICE STILL ON PATIENT) - THE SURGERY WAS COMPLETED WITH DEVICE - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE (NOT REQUIRED CURRENTLY) - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE - PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS CURRENTLY OTHER THAN INFECTED PIN SITE. ON (B)(6) 2016, ORTHOFIX RECEIVED THE IMAGES WITH THE LOT NUMBER & CODE OF THE DEVICES INVOLVED IN THIS EVENT: -(B)(4) LOT 1506390 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00090) AND - (B)(4) LOT 1508633 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00092). ON (B)(6) 2016, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION TOGETHER WITH A PICTURE OF THE WHOLE FRAME: - DATE OF THE INITIAL SURGERY: TBC. HOWEVER, LIKELY TO BE DURING (B)(6) 2015 ( THROUGH SALES ORDER OF PURCHASED ITEMS BY THE CUSTOMER & HDT) - DATE THE INCIDENT OCCURRED: INCIDENT REPORTED (B)(6) 2016 - MOREOVER, ON (B)(6) DURING A ROUTINE CLINIC APPOINTMENT, ALSO TWO RAPID STRUTS (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2016-00098 AND 9680825-2016-00099) AND ONE TL WIRE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00100) WERE FOUND BROKEN. THE TWO STRUTS WERE REPLACED IN THAT DATE. NO INFORMATION HAS BEEN RECEIVED IN REGARDS TO THE WIRE. ON (B)(6) 2016, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON: - I HAVE THE BROKEN RAPID STRUTS IN MY OFFICE BUT THEY ARE NOT DECONTAMINATED. THE BROKEN WIRE FROM TALUS WAS DISPOSED OF IN A SHARPS BIN AT THE TIME. ON (B)(6) 2016, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: "UNEXPECTEDLY, MR (B)(4) HAS KINDLY RETURNED FATIGUED TL+ EXTENSION FOOT PLATES FOR THE INVESTIGATION. ALTHOUGH, HE TOLD IT IS DECONTAMINATED (IT IS IN STERILIZATION PACKET), BUT UNFORTUNATELY NO DECON RECEIVED ALONG WITH IT". PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: NOT PROVIDED, BATCH NUMBER: NOT PROVIDED, QUANTITY: 1, HOSPITAL NAME: (B)(6), SURGEON NAME: MR (B)(6), DATE OF SURGERY: UNKNOWN, DATE REPORTED: (B)(6) 2016, BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/FOOT, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT INFORMATION: MALE, PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: FATIGUE OF THE JOINT OF THE FOOT PLATE AND FOOT PLATE EXTENSION PLATES, 1 SIDE SHOWS EARLY SIGNS OF FATIGUE (HAIR LINE CRACK) AND THE OTHER MORE OBVIOUS SIGNS OF FATIGUE. ADVICE GIVEN TO SURGEON AS TO BRIDGE THE AREA OF FATIGUE TO PREVENT FAILURE. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT (ALTHOUGH DEVICE STILL ON PATIENT) - THE SURGERY WAS COMPLETED WITH DEVICE, - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE, - AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE (NOT REQUIRED CURRENTLY), - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE, - COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE, - PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS CURRENTLY OTHER THAN INFECTED PIN SITE. ON OCTOBER 5, 2016, ORTHOFIX RECEIVED THE IMAGES WITH THE LOT NUMBER & CODE OF THE DEVICES INVOLVED IN THIS EVENT: - CODE 56-14590 LOT 1506390 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00090) AND - CODE 56-14590 LOT 1508633 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00092). ON NOVEMBER 9, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION TOGETHER WITH A PICTURE OF THE WHOLE FRAME: - DATE OF THE INITIAL SURGERY: TBC. HOWEVER, LIKELY TO BE DURING (B)(6) 2015 (THROUGH SALES ORDER OF PURCHASED ITEMS BY THE CUSTOMER & HDT). - DATE THE INCIDENT OCCURRED: INCIDENT REPORTED (B)(6) 2016. - MOREOVER, ON NOVEMBER 7, DURING A ROUTINE CLINIC APPOINTMENT, ALSO TWO RAPID STRUTS (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2016-00098 AND 9680825-2016-00099) AND ONE TL WIRE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00100) WERE FOUND BROKEN. THE TWO STRUTS WERE REPLACED IN THAT DATE. NO INFORMATION HAS BEEN RECEIVED IN REGARDS TO THE WIRE. ON NOVEMBER 17, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON: - I HAVE THE BROKEN RAPID STRUTS IN MY OFFICE BUT THEY ARE NOT DECONTAMINATED. THE BROKEN WIRE FROM TALUS WAS DISPOSED OF IN A SHARPS BIN AT THE TIME. ON DECEMBER 6, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: "UNEXPECTEDLY, MR (B)(6) HAS KINDLY RETURNED FATIGUED TL+ EXTENSION FOOT PLATES FOR THE INVESTIGATION. ALTHOUGH, HE TOLD IT IS DECONTAMINATED (IT IS IN STERILIZATION PACKET), BUT UNFORTUNATELY NO DECON RECEIVED ALONG WITH IT". PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099. (B)(4).
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: QUANTITY: 1; HOSPITAL NAME: (B)(6); SURGEON NAME: MR (B)(6); DATE OF SURGERY: UNKNOWN, DATE REPORTED: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA/FOOT; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: MALE; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: FATIGUE OF THE JOINT OF THE FOOT PLATE AND FOOT PLATE EXTENSION PLATES, 1 SIDE SHOWS EARLY SIGNS OF FATIGUE (HAIR LINE CRACK) AND THE OTHER MORE OBVIOUS SIGNS OF FATIGUE (PLEASE SEE IMAGE - FRAME REMAINS ON THE PATIENT). ADVICE GIVEN TO SURGEON AS TO BRIDGE THE AREA OF FATIGUE TO PREVENT FAILURE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT (ALTHOUGH DEVICE STILL ON PATIENT); THE SURGERY WAS COMPLETED WITH DEVICE; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE (NOT REQUIRED CURRENTLY); COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS CURRENTLY OTHER THAN INFECTED PIN SITE. ON OCTOBER 5, 2016, ORTHOFIX RECEIVED THE IMAGES WITH THE LOT NUMBER AND CODE OF THE DEVICES INVOLVED IN THIS EVENT: CODE 56-14590 LOT 1506390 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00090); CODE 56-14590 LOT 1508633 (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00092). ON NOVEMBER 9, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION TOGETHER WITH A PICTURE OF THE WHOLE FRAME: DATE OF THE INITIAL SURGERY: TBC. HOWEVER, LIKELY TO BE DURING (B)(6) 2015 ( THROUGH SALES ORDER OF PURCHASED ITEMS BY THE CUSTOMER AND HDT); DATE THE INCIDENT OCCURRED: INCIDENT REPORTED (B)(6) 2016; MOREOVER, ON (B)(6) DURING A ROUTINE CLINIC APPOINTMENT, ALSO TWO RAPID STRUTS (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2016-00098 AND 9680825-2016-00099) AND ONE TL WIRE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00100) WERE FOUND BROKEN. THE TWO STRUTS WERE REPLACED IN THAT DATE. NO INFORMATION HAS BEEN RECEIVED IN REGARDS TO THE WIRE. ON NOVEMBER 17, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON: I HAVE THE BROKEN RAPID STRUTS IN MY OFFICE BUT THEY ARE NOT DECONTAMINATED. THE BROKEN WIRE FROM TALUS WAS DISPOSED OF IN A SHARPS BIN AT THE TIME. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-20106-00090, 9680825-2016-00092, 9680825-2016-00098, 9680825-2016-00099. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 776527 | TRUE LOK WIRE | TRUE LOK WIRE | KTT | ORTHOFIX SRL | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |