TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
Report
- Report Number
- 9680825-2023-00033
- Event Type
- Injury
- Date Received
- August 9, 2023
- Report Date
- October 23, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K212044
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS - ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B2985789 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2023 WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B2361453 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2022 WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON AUGUST 21, 2023, WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THEY WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE OUTER TUBE, SUBCOMPONENT CODE 8860051, OF ALL RETURNED DEVICES IS SEPARATED FROM THE FEMALE END PART, SUBCOMPONENT CODE 8860026. GLUE RESIDUES ARE VISIBLE ON THE INNER PART OF THE OUTER TUBE AND ON THE FEMALE END PART OF ALL RETURNED DEVICES. THE VISUAL CHECK ALSO EVIDENCED THAT ALL THE RETURNED STRUTS WERE RECEIVED WITH THE CENTRAL LOCK FIRMLY TIGHTENED. NO ISSUES WERE DETECTED. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK ON THE RETURNED STRUTS AS THEY ARE SEPARATED AND NOT FUNCTIONING ANYMORE. FUNCTIONAL STATIC TEST WAS PERFORMED ON FIVE STRUTS FROM A RECENT PRODUCTION LOT. ALL DEVICES TESTED MET ORTHOFIX SPECIFICATIONS. TEST PASSED. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE EVALUATION PERFORMED. IN THIS CASE THE PATIENT IS 1.82M AND 125KG. THE PATIENT HAD A FRAME WITH FOUR LONG STRUTS AND WAS WEIGHTBEARING. THE FRAME HAS COLLAPSED DRAMATICALLY WITH DISLOCATION OF THE DISTAL JOINT OF EACH STRUT. THIS MUST HAVE BEEN DUE TO LOADING OF THE STRUTS BEYOND THE DESIGN CRITERIA. THIS PATIENT SHOULD HAVE BEEN PARTIALLY WEIGHTBEARING AND I SUSPECT THAT IN FACT HE WAS FULLY WEIGHTBEARING AT TIMES. REOPERATION WAS REQUIRED TO REPLACE THE STRUTS AND CORRECT THE POSITION. THE STRUTS DISASSEMBLED AT THE GLUED JOINT AT THE DYNAMIC END. THE JOINTS WERE ASSEMBLED CORRECTLY, AND RECENT MECHANICAL TESTING OF A BATCH OF EQUIVALENT DEVICES HAS SHOWN THAT THEY ARE PERFORMING WELL ABOVE THE ORIGINAL DESIGN CRITERIA. AS THE TECHNICAL ANALYSIS HAS COMMENTED, WE HAVE BEEN GIVEN NO INFORMATION ABOUT THE CIRCUMSTANCES OF THE USE OF THIS FRAME, INCLUDING PATIENT MOBILITY. I CAN ONLY SUGGEST THAT THEY MUST HAVE BEEN SIGNIFICANTLY OVERLOADED BY A SUDDEN EVENT OF SOME SORT. FINAL COMMENTS THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATION. THE FAILURE OCCURRED SEEMS TO BE RELATED TO A SIGNIFICANT OVERLOAD APPLIED ON THE FRAME CAUSING THE DISASSEMBLING OF THE FOUR STRUTS AT THE SAME TIME. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2023-00034 AND 9680825-2023-00035 AND 9380825-2023-00036.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B2985789 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2023 WAS COMPRISED OF 20 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RECEIVED BY ORTHOFIX SRL YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. 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 ARE AVAILABLE. AS SOON AS FURTHER INFORMATION IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2023-00034 AND 9680825-2023-00035 AND 9380825-2023-00036.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-886005 (QUANTITY 4) - (MIR REPORTS:9680825-2023-00033 AND 9680825-2023-00034 AND 9680825-2023-00035 AND 9680825-2023-00036). HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT LOWER EXTREMITY F&A. - SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: 70 YEAR-OLD, MALE, WEIGHT APPROX. 125 KG., HEIGHT APPROX. 180 CM, WITH DIABETES. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: ALL FOUR STRUTS DISASSOCIATED AT THE DYNAMIC MECHANISM TWO WEEKS POST OPERATIVELY. PATIENT WAS WEIGHTBEARING. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF CORRECTION AND REOPERATION. 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 REQUIRED: PERFORMED ON (B)(6) 2023. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2023. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: STABLE. WOUND IS HEALING . STRUT SWAP ON (B)(6) 2023. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2023-00034 AND 9680825-2023-00035 AND 9680825-2023-00036. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-886005 (QUANTITY 4) - (MIR REPORTS:9680825-2023-00033 AND 9680825-2023-00034 AND 9680825-2023-00035 AND 9680825-2023-00036) - HOSPITAL NAME: (B)(6) - SURGEON'S NAME: (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2023 - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT LOWER EXTREMITY F&A - SURGERY DESCRIPTION: CORRECTION - PATIENT INFORMATION: 70 YEAR-OLD, MALE, WEIGHT APPROX. 125 KG., HEIGHT APPROX. 180 CM, WITH DIABETIES - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: ALL FOUR STRUTS DISASSOCIATED AT THE DYNAMIC MECHANISM TWO WEEKS POST OPERATIVELY. PATIENT WAS WEIGHTBEARING. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF CORRECTION AND REOPERATION - 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 REQUIRED: PERFORMED ON (B)(6) 2023. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: PERFORMED ON (B)(6) 2023 - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PATIENT CURRENT HEALTH CONDITION: STABLE. WOUND IS HEALING . STRUT SWAP ON (B)(6) 2023. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2023-00034 AND 9680825-2023-00035 AND 9680825-2023-00036 MANUFACTURER REFERENCE NUMBER:(B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1588651 | TRUELOK EVO RX STRUT LONG WITH DYNA STERILE | TRUELOK EVO RX STRUT LONG WITH DYNA STERILE | KTT | ORTHOFIX SRL | B2985789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |