TL PLUS FULL RING, 160MM
Report
- Report Number
- 9680825-2021-00039
- Event Type
- Injury
- Date Received
- May 6, 2021
- Date of Event
- March 3, 2021
- Report Date
- September 24, 2021
- Manufacturer
- ORTHOFIX SRL
- Product Code
- LXT
- UDI-DI
- 18033509857041
- PMA / PMN Number
- K941048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 56-10930 BATCH 1708267 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) UNITS, ASSEMBLED IN THE FINISHED DEVICE BATCH B1200340. ALL OF THEM HAVE BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 56-10930 BATCH 1903624 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039) THE RETURNED DEVICES, RECEIVED ON JUNE 29, 2021, WERE EXAMINED BY ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SPECIFICATIONS. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: 1). THE RING BATCH 1708267 IS BROKEN. THE BROKEN FRAGMENT HAS BEEN RETURNED AS WELL. 2). THE RING BATCH 1903624 HAS A TRANSVERSE CRACK. THE SURFACE OF THE BROKEN FRAGMENT SHOWS EVIDENT SIGNS OF CORROSION. THE VISUAL CHECK ALSO EVIDENCED SEVERAL DIMPLE SIGNS ON BOTH RINGS WHICH COULD BE RELATED TO EXCESSIVE TORQUE APPLIED DURING TIGHTENING WITH NUTS. THE DIMENSIONAL CHECK CONFIRMED THAT THE THICKNESS OF THE RINGS IS IN CONFORMANCE WITH ORTHOFIX SPECIFICATIONS. NO ANOMALIES WERE DETECTED. THE FUNCTIONAL CHECK WAS NOT PERFORMED AS THE DEVICES ARE DAMAGED. IT WAS ALSO PERFORMED THE DOCUMENTAL CHECK OF THE RAW MATERIAL USED TO PRODUCE THE BROKEN RINGS. NO ISSUE WAS FOUND. FROM THE VISUAL EXAMINATION OF THE BROKEN SURFACES, THE TECHNICAL EVALUATION CONCLUDED THAT THE FAILURE OCCURRED IS MAINLY ATTRIBUTABLE TO STRESS CORROSION (COMBINATION OF OXIDATION AND MECHANICAL STRESS). THIS CONCLUSION IS SUPPORTED BY THE PICTURES THE CUSTOMER PROVIDED, WHICH SHOW THE TL FRAME CONFIGURATION. FROM A VERIFICATION OF THE FRAME CONFIGURATION, IT WAS EVIDENCED THAT THE SECTION FORMED BY TWO BONE SCREWS AND TWO THREADED RODS (BLACK SQUARE) FORMED A VERY RIGID CONFIGURATION. THE ABSENCE OF ANY BONE SCREW ON THE RIGHT SECTION MAY HAVE IMPACTED ON SYSTEM BALANCE, CAUSING OVERLOAD ON RINGS IN THAT SPECIFIC AREA. IT IS ALSO EVIDENT THAT DURING LENGTHENING TREATMENT THE FRAME CONFIGURATION WAS CHANGED: ONE STRUT (GREEN CIRCLED) IS NOT PRESENT IN THE PICTURE TAKEN AT A LATER DATE, WHILE THE OTHERS STRUTS WERE REPLACED WITH OTHER DISTRACTION ELEMENTS. PICTURES TAKEN AFTER FAILURE EVIDENCED THAT LOWER RING BREAKAGE OCCURRED NEAR SCREW INSERTION. THE SIGNS OF CORROSION PRESENT ON THE BROKEN SURFACE SUGGESTS THE USE OF AGGRESSIVE DETERGENT TO CLEAN THE PIN SITE. MEDICAL EVALUATION (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039) THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW A SUMMARY OF THE MEDICAL EVALUATIONS PERFORMED. (B)(6) 2021: "A MALE PATIENT OF 24 YEARS WAS HAVING A CORRECTION TO HIS LEFT LEG WITH A TRUELOK FRAME. THE PATIENT WAS WEIGHTBEARING AT HOME IN THE 8TH WEEK OF TREATMENT, AND HEARD A CRACK, AND NOTICED THAT ONE RING WAS BROKEN. IT WAS FOUND THAT ONE RING WAS BROKEN AND A SECOND WAS CRACKED. APPARENTLY, THE 160 MM COMPLETE RINGS WERE REPLACED IN THE DOCTOR'S OFFICE. THIS WOULD HAVE BEEN POSSIBLE IF THE BONE FIXATION WAS WITH BONE SCREWS AND NOT TENSIONED WIRES. IT WOULD BE IMPOSSIBLE TO CHANGE A RING IF TENSIONED WIRES WERE USED IN THE FRAME. A PROXIMAL RING COULD BE REPLACED WITH 2 HALF RINGS OF THE SAME DIAMETER". (B)(6) 2021 WITH FURTHER INFORMATION RECEIVED: "THE RINGS BROKE 24 WEEKS AFTER THE ORIGINAL OPERATION. WE ALSO NOW KNOW THAT AN ADDITIONAL OPERATION WAS REQUIRED TO CONTINUE TREATMENT, BUT ORTHOFIX RINGS WERE NOT USED BECAUSE OF A LACK OF INSURANCE. THE NATURE OF THE CONTINUING TREATMENT WAS NOT SPECIFIED. WE CAN SUPPOSE THAT THE PATIENT, AN 80 KG 24 YEAR OLD MALE, WAS ACTIVE IN THE 24 WEEKS AND CREATED A LOADING HISTORY THAT SURPASSED THE RING SPECIFICATION". (B)(6) 2021 WITH THE OUTCOME OF THE TECHNICAL ANALYSIS: "THIS TECHNICAL ANALYSIS MAKES IT VERY CLEAR THAT THESE RINGS HAD BEEN SUBJECT TO CORROSIVE ACTION, PROBABLY BY A CLEANSING AGENT. THE RINGS ARE DESIGNED TO TAKE CONSIDERABLE REPETITIVE MECHANICAL LOADING BUT CAN ONLY DO SO IF THEY ARE INTACT. ALSO, THE TECHNICAL ANALYSIS MAKES SOME EXCELLENT POINTS: 1). THE 2 THREADED RODS WITHIN THE BLACK RECTANGLE ARE QUITE CLOSE TOGETHER, AND FORM A RELATIVELY RIGID BLOCK COMPARED WITH THE LATERAL SECTION OF RING, WHICH AS A RESULT WILL FLEX TO A GREATER EXTENT THAN THE RING ENCLOSED WITHIN THE RIGID BLOCK. THIS WILL LEAD TO A CONCENTRATION OF CYCLIC FLEXION JUST LATERAL TO THE ANTERIOR ROD IN THE DISTAL RING, WHICH IS EXACTLY WHERE THE RING BROKE; 2). AND IT ALSO EMPHASISES THE IMPORTANCE OF SPREADING THE THREADED ROD ATTACHMENTS TO THE RINGS EVENLY AROUND THE CIRCUMFERENCE, WHETHER 3 OR 4 CONNECTING ELEMENTS ARE USED, AGAIN WITH THE AIM OF EVENING OUT THE LOADING ON THE RINGS". CONCLUSION: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATIONS. THE BREAKAGE OCCURRED IS MAINLY ATTRIBUTABLE TO STRESS CORROSION (COMBINATION OF OXIDATION AND MECHANICAL STRESS). THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THESE SPECIFIC LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 56-10930 (TL PLUS FULL RING, 160MM). BATCH NUMBERS: 1708267 AND 1903624 (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039 RESPECTIVELY). QUANTITY: 1 EACH. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT LEG. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 24 YEARS, MALE, 80 KG, 175 CM IN GOOD HEALTH CONDITION. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "NA 8° SEMANA DE TRATAMENTO APÓS JÁ TER FEITO O ALONGAMENTO O PACIENTE OUVIU UM ESTALO AO CAMINHAR EM CASA E PERCEBEU QUE UM DOS ANÉIS HAVIA QUEBRADO E O OUTRO TRINCADO. PACIENTE FOI SUBMETIDO A UMA REVISÃO PARA TROCA DOS ANÉIS QUEBRADOS - IN THE 8TH WEEK OF TREATMENT, AT THE END OF THE LENGTHENING, THE PATIENT HEARD A CRACK WHEN WALKING AT HOME AND REALIZED THAT ONE OF THE RINGS HAD BROKEN AND THE OTHER ONE CRACKED. THE PATIENT UNDERWENT A REVIEW TO REPLACE THE BROKEN RINGS.". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: THE PATIENT'S CONDITION IS GOOD AND STABLE. FURTHER INFORMATION AND PICTURES RECEIVED ON APRIL 29, 2021 FROM THE LOCAL DISTRIBUTOR: THE RING BROKEN ON (B)(6) 2021. THE TWO RINGS WERE REPLACED BY ADDITIONAL SURGERY, BUT ONCE THE PATIENT HADN'T HEALTH INSURANCE THE SURGEON COULDN'T PERFORM THE REPLACEMENT WITH ORTHOFIX'S RINGS. THE DATE OF THE DEVICES REPLACEMENT IS (B)(6) 2021. THE X-RAY IMAGES ARE NOT AVAILABLE. RECEIVED ONLY SOME PICTURES. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: 005/2021 PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2021-00038.
ANALYSIS OF HISTORICAL RECORDS (MFR REPORTS 9680825-2021-00038 AND 9680825-2021-00039) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE (B)(4)BATCH 1708267 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) UNITS, ASSEMBLED IN THE FINISHED DEVICE BATCH B1200340. ALL OF THEM HAVE BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE (B)(4)BATCH 1903624 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (MFR REPORTS 9680825-2021-00038). THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL 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 (MFR REPORTS 9680825-2021-00038). 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 ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: (B)(4) (TL PLUS FULL RING, 160 MM). BATCH NUMBERS: 1708267 AND 1903624 (MFR REPORTS 9680825-2021-00038 RESPECTIVELY). QUANTITY: 1 EACH. DATE OF INITIAL SURGERY: (B)(6) 2020. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT LEG. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: (B)(6), MALE, (B)(6) KG, 175 CM IN GOOD HEALTH CONDITION. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "NA 8° SEMANA DE TRATAMENTO APÓS JÁ TER FEITO O ALONGAMENTO O PACIENTE OUVIU UM ESTALO AO CAMINHAR EM CASA E PERCEBEU QUE UM DOS ANÉIS HAVIA QUEBRADO E O OUTRO TRINCADO. PACIENTE FOI SUBMETIDO A UMA REVISÃO PARA TROCA DOS ANÉIS QUEBRADOS - IN THE 8TH WEEK OF TREATMENT, AT THE END OF THE LENGTHENING, THE PATIENT HEARD A CRACK WHEN WALKING AT HOME AND REALIZED THAT ONE OF THE RINGS HAD BROKEN AND THE OTHER ONE CRACKED. THE PATIENT UNDERWENT A REVIEW TO REPLACE THE BROKEN RINGS." THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITIONS: THE PATIENT'S CONDITION IS GOOD AND STABLE. FURTHER INFORMATION AND PICTURES RECEIVED ON APRIL 29, 2021 FROM THE LOCAL DISTRIBUTOR: THE RING BROKEN ON (B)(6) 2021. THE TWO RINGS WERE REPLACED BY ADDITIONAL SURGERY, BUT ONCE THE PATIENT HADN'T HEALTH INSURANCE THE SURGEON COULDN'T PERFORM THE REPLACEMENT WITH ORTHOFIX'S RINGS. THE DATE OF THE DEVICES REPLACEMENT IS (B)(6) 2021. THE X-RAY IMAGES ARE NOT AVAILABLE. RECEIVED ONLY SOME PICTURES. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2021-00038.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683653 | TL PLUS FULL RING, 160MM | TL PLUS FULL RING, 160MM | LXT | ORTHOFIX SRL | 1 | 1903264 | 18033509857041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |