TRUELOK EVO RX FOOT ARCH D200MM STERILE
Report
- Report Number
- 9680825-2023-00027
- Event Type
- Malfunction
- Date Received
- June 27, 2023
- Report Date
- October 16, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K212044
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-884200 BATCH B1684575 MARKED ON THE COMPONENT (B)(6) , BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF (B)(4). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED FOR THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE RETURNED DEVICE, RECEIVED ON 13 JUNE 2023, WAS EXAMINED BY ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT. THE DEVICE WAS SUBJECT TO VISUAL CHECK AS PER ORTHOFIX SRL DESIGN AND PRODUCT SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE GLUING FOR THE FIXING BETWEEN THE CONNECTOR ARC-2 CODE (B)(6) AND THE HALF RING CODE (B)(6) HAS FAILED ON ONE EXTREMITY. THE CONNECTOR IS CRACKED, LIKELY DUE TO THE FAILURE OF THE GLUING CONNECTION. THE EDGE AT THE SAME SIDE OF THE CRACK PRESENTS A SLIGHT DEFORMATION, POSSIBLY DUE TO A BENDING STRESS. NO ANOMALIES WERE DETECTED IN THE ASSEMBLY PROCEDURE WITH THE GLUE, WHICH IS APPLIED UNIFORMLY ON THE SURFACE OF THE DEVICE. THE TWO CONNECTORS ARC-FOOTPLATE, REFERENCE CODE (B)(6) ARE WORN ON THE EXTREMITY. THIS IS LIKELY DUE TO WEAR WHILE IN USE ON PATIENT. OTHER SIGNS OF USE HAVE BEEN DETECTED. LASER MARKING IS CLEARLY VISIBLE. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE DEVICE IS BROKEN. THE CHECK OF THE RAW MATERIAL CERTIFICATE CONFIRMS THAT IT IS IN CONFORMITY WITH SPECIFICATIONS. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT, WITH THE OUTCOME OF THE TECHNICAL EVALUATION, WAS SENT TO OUR MEDICAL CONSULTANT. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. UNFORTUNATELY, WE DO NOT KNOW WHEN THIS FIXATOR WAS APPLIED, AND THE PATHOLOGY BEING TREATED. IT WOULD BE HELPFUL TO KNOW HOW STIFF THE BONE MIGHT BE AT THIS POINT TO JUDGE THE LIKELIHOOD OF LOSS OF POSITION. I WOULD GUESS THAT THE WIRES ACROSS THE FOOT ARCH WILL HAVE LESS TENSION THAN BEFORE AFTER THE ARCH HAS BROKEN, AND THIS WILL AFFECT THE FIXATION STABILITY AND POSSIBLY CAUSE LOSS OF POSITION. THE FACT THAT THE SURGEON HAS NOT REPLACED THE ARCH SUGGESTS THAT HE DOES NOT THINK IT IS SERIOUS, BUT THEY CORRECTLY SUGGEST IN THE REPORT THAT FAILURE OF ANOTHER FRAME COMPONENT IS NOW MORE LIKELY THAN BEFORE. THIS IS A VERY DETAILED TECHNICAL ANALYSIS AND A VERY INTERESTING INSIGHT INTO THE MANUFACTURING PROCESS. THE JOINT AT THE END OF THE ARCH SEPARATED; IT SEEMS THAT THE GLUED JOINT CAME APART, AND THIS WAS TRIGGERED BY A CRACK AND DEFORMATION IN THE FEMALE PART OF THE JOINT. THIS MUST HAVE BEEN DUE TO A SUDDEN LOAD BEING APPLIED, SUCH AS A MIS-STEP IN WEIGHTBEARING. I NOTE THAT THE GLUE APPLICATION WAS FULLY TO SPECIFICATION. THIS IS THE FIRST SUCH INCIDENT TO BE REPORTED. SO WE CAN CONCLUDE THAT THIS COMPONENT BROKE BECAUSE OF A SUDDEN EXCESSIVE LOAD BEYOND THE DESIGN CRITERIA. AS STATED IN THE TECHNICAL ANALYSIS, WE HAVE BEEN GIVEN NO INFORMATION AS TO HOW THE FRAME WAS LOADED, SO WE ARE UNABLE TO MAKE ANY COMMENTS ON THE MODE OF USE. FINAL COMMENTS: THE INVESTIGATION PERFORMED EVIDENCED THE PRESENCE OF A CRACK ON THE ALUMINUM CONNECTOR, NEAR ONE OF THE EDGES. CRACK INITIATION AND PROPAGATION ARE LIKELY RELATED WITH AN EXTERNAL STATIC OVERLOAD. THE DEFORMATION ON ONE OF THE TWO LONGER EDGES SUGGESTS THE PRESENCE OF BENDING STRESS ON THE FRAME. THE GLUE APPLICATION IS IN CONFORMITY WITH SPECIFICATIONS. FROM THE EVIDENCE COLLECTED DURING THE VISUAL INVESTIGATION, IT IS SUGGESTED THAT THE FAILURE NOTIFIED IS RELATED TO AN UNEXPECTED EXTERNAL OVERLOAD. UNFORTUNATELY, THIS CANNOT BE SURELY CONFIRMED, AS NO INFORMATION HAS BEEN PROVIDED CONCERNING THE CIRCUMSTANCES OF THE FAILURE, LOADING HISTORY OF THE FRAME, OR TREATMENT. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
TECHNICAL EVALUATION: THE DEVICE INVOLVED RECEIVED AT ORTHOFIX ON 13 JUNE 2023, IS UNDERGOING THE CLEANING AND STERILIZATION ACTIVITIES. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE AFTER STERILIZATION. 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 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: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON'S NAME: (B)(6); DATE OF INITIAL SURGERY: UNKNOWN; BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; SURGERY DESCRIPTION: CORRECTION; PATIENT'S INFORMATION: UNKNOWN; PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: BREAKAGE OF THE CONNECTION. NO EXTRA SURGERY REQUIRED YET, BUT POTENTIAL WIRE LOOSENING WITH FUTURE EXPECTED BREAKAGE. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD 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; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPY OF OPERATIVE REPORTS IS NOT AVAILABLE; COPY OF X-RAY IMAGES IS NOT AVAILABLE; THE PROBLEM OCCURRED DURING THE FIRST USE OF THE DEVICE; PATIENT'S CURRENT HEALTH CONDITION: N/A. MANUFACTURER REF: (B)(4).; DISTRIBUTOR REF: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: (B)(6) HOSPITAL. SURGEON'S (B)(6). DATE OF INITIAL SURGERY: UNKNOWN. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: BREAKAGE OF THE CONNECTION. NO EXTRA SURGERY REQUIRED YET, BUT POTENTIAL WIRE LOOSENING WITH FUTURE EXPECTED BREAKAGE. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD 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. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF X-RAY IMAGES IS NOT AVAILABLE. THE PROBLEM OCCURRED DURING THE FIRST USE OF THE DEVICE. PATIENT'S CURRENT HEALTH CONDITION: N/A. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1540949 | TRUELOK EVO RX FOOT ARCH D200MM STERILE | TRUELOK EVO RX FOOT ARCH D200MM STERILE | KTT | ORTHOFIX SRL | 99-884200 | B1684575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |