TRUELOK EVO RX STRUT LONG WITH DYNA STERILE
Report
- Report Number
- 9680825-2023-00002
- Event Type
- Injury
- Date Received
- March 9, 2023
- Date of Event
- February 20, 2023
- Report Date
- April 6, 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 B1693140R BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 35 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 (MFR REPORTS 9680825-2023-00003 AND 9380825-2023-00004). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1690090R BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, 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 (MFR REPORT 9680825-2023-00005). TECHNICAL EVALUATION (MFR REPORTS 9680825-2023-00003 AND 9380825-2023-00004 AND 9680825-2023-00005) THE DEVICES INVOLVED IN THIS EVENT HAVE BEEN RECEIVED BY ORTHOFIX SRL ON MARCH 3, 2023. THE TECHNICAL EVALUATION ON THE RETURNED DEVICES IS CURRENTLY ONGOING. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1693140R BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 35 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 (MFR REPORTS 9680825-2023-00002 AND 9680825-2023-00003 AND 9380825-2023-00004). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1690090R BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 126 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 (MFR REPORT 9680825-2023-00005). TECHNICAL EVALUATION (MFR REPORTS 9680825-2023-00002 AND 9680825-2023-00003 AND 9380825-2023-00004 AND 9680825-2023-00005). THE RETURNED DEVICES, RECEIVED ON MARCH 3, 2023, WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE RETURNED DEVICES WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK EVIDENCED THAT THE OUTER TUBE OF ALL RETURNED DEVICES IS SEPARATED FROM THE FEMALE END PART. GLUE RESIDUES ARE VISIBLE ON THE INNER PART OF THE OUTER TUBE AND ALSO 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 OTHER 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 TESTS WERE PERFORMED ON 5 STRUTS FROM A RECENT PRODUCTION (LOT B2867634). ALL THE DEVICES TESTED MET THE DESIGN SPECIFICATION. TEST PASSED. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT A SUDDEN OVERLOAD WAS APPLIED TO THE FRAME CAUSING THE FAILURE OF THE 4 STRUTS AND OF AN INTERNAL PLATE FROM ANOTHER MANUFACTURER. MEDICAL EVALUATION (MFR REPORTS 9680825-2023-00003 AND 9380825-2023-00004 AND 9680825-2023-00005). 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 FROM THE USA, A MALE PATIENT OF 57 YEARS WEIGHING 136 KG SUSTAINED AN ANKLE FRACTURE, WHICH WAS TREATED WITH A TRUELOK EVO FRAME TO THE TIBIA AND A TUBULAR PLATE TO THE FIBULA. THE PATIENT WAS IN CUSTODY WITH 2 CUSTODIAL ATTENDANTS. THE INITIAL FIXATION WAS CARRIED OUT ON FEBRUARY 8TH WITH 4 LONG DYNA STRUTS. 2 WEEKS LATER IT WAS NOTED THAT THE 4 DYNA STRUTS WERE ALL BROKEN, AS WAS THE FIBULAR PLATE, AND THE FRACTURE REDUCTION WAS LOST. THE EVO STRUTS WERE REMOVED AND REPLACED WITH 6 QUICK REDUCE STRUTS, BUT THE FRACTURE POSITION WAS POOR WITH A SUBLUXED ANKLE JOINT, AS SEEN ON THE X-RAY. THE SURGEON WISHED TO CHANGE THE FIXATION TO AN ANKLE NAIL, BUT THE PATIENT HAD A CARDIAC EPISODE AND IS NOT FIT FOR SURGERY AT PRESENT. THE STORY WAS THAT THE FIXATION JUST COLLAPSED WHILE THE PATIENT WAS IN BED. CERTAINLY, ANY FIXATION OF THE ANKLE WOULD BE SUBJECT TO SEVERE LOADS IN A PATIENT OF THIS WEIGHT. THIS EVENT IS CERTAINLY TO BE CLASSIFIED AS A SEVERE INJURY AND IS EXACERBATED IN THIS CASE BY THE DELAY CAUSED BY THE PATIENT'S HEART CONDITION. PROVIDED THAT THE PATIENT'S CARDIAC STATUS IS IMPROVED, THERE SHOULD BE NO LONG TERM HARM AND THE FRACTURE CAN BE REDUCED AND FIXED IN POSITION. THE REASON THAT THE EVO DYNA STRUTS "BROKE" AS DESCRIBED IS BECAUSE A JOINT IN EACH UNIT THAT IS ASSEMBLED WITH GLUE HAS COME APART. THE GLUING SEQUENCE IS DETAILED CLEARLY IN THE TECHNICAL ANALYSIS, AND THE GLUE IS DISTRIBUTED THROUGHOUT EACH OF THE FAILED JOINTS ACCORDING TO SPECIFICATION. THE TECHNICAL ANALYSIS CONCLUDES, AND I FULLY AGREE, THAT FOR 4 DYNA STRUTS AND A TUBULAR FIBULAR PLATE ALL TO FAIL AT THE SAME MOMENT, THERE MUST HAVE BEEN A SUDDEN SEVERE LOAD ON THE FIXATION, WHICH IS NOT UNLIKELY CONSIDERING THE WEIGHT OF THE PATIENT. I CONSIDER THAT THIS FIXATION MUST HAVE BEEN SUBJECT TO LOADS GREATER THAN THE DESIGN CRITERIA". CONCLUSIONS 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 SUDDEN SEVERE LOAD ON THE FIXATION. THIS ASSUMPTION IS CONFIRMED BY THE FACT THAT 4 STRUTS AND A SMITH&NEPHEW PLATE ALL FAILED AT THE SAME MOMENT. 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.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-886005 (QUANTITY 4) - (MFR REPORTS: 9680825-2023-00003 AND 9680825-2023-00004 AND 9680825-2023-00005). - HOSPITAL NAME: (B)(6) HOSPITAL. - SURGEON'S NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023. - BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 57 YEARS, MALE, 300 LB, IN POOR HEALTH CONDITION. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - EVENT DESCRIPTION: "EVO RINGS AND FOOTPLATE APPLIED FOR ANKLE FRACTURE. 4 LONG STRUTS WITH DYNA WERE USED. SMITH AND NEPHEW TUBULAR PLATE USED ON FIBULA. PATIENT WAS ADMITTED TO THE HOSPITAL IMMEDIATELY POST SURGERY DUE TO AN UNDERLYING HEART CONDITION. PATIENT IS FROM A CORRECTIONAL FACILITY AND HAS TWO 24/7 OFFICERS STATIONED WITH HIM AT ALL TIMES. DR (B)(6) RECEIVED NOTICE FROM THE FLOOR NURSE THAT HIS STRUT WAS BROKEN. DR (B)(6), THE ORTHO RESIDENT AND MYSELF WENT TO THE PATIENTS ROOM TO FIND THAT ALL FOUR STRUTS WERE BROKEN IN HALF. ALL STRUTS WERE REMOVED AND 6 RAPID ADJUST STRUTS WERE APPLIED TO THE FRAME. XRAYS REVELED THAT THE SN PLATE WAS BROKEN IN HALF AND THE ANKLE SUBLUXED. THE PATIENT IS AWAITING HEART SURGERY BEFORE HE CAN RETURN TO THE OR UNDER ORTHOPAEDIC SERVICE. HE WAS SCHEDULED TO HAVE AN AHN ON (B)(6) 2023 DUE TO SUBLUXATION. THE SURGERY WAS CANCELED BY ANETHESIA DUE TO HIS HEART. THE PATIENT CLAIMS "THEY JUST BROKE WHEN I WAS LAYING IN BED". HE DENYS WALKING OR FALLING. THE CORRECTIONAL OFFICERS CLAIM NO KNOWLEDGE OF ANY INCIDENT.". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION AND LOSS OF ACHIEVED CORRECTION). - 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. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. - PATIENT CURRENT HEALTH CONDITION: CURRENTLY AWAITING BYPASS SURGERY. HIS CURRENT HEART CONDITION PREVENTS HIM FROM HAVING ANY ORTHOPAEDIC SURGERY TO CORRECT THE SUBLUXATION OF THE ANKLE. DR (B)(6) PLAN IS TO FUSE THE ANKLE WITH AHN ONCE THE PATIENT IS CLEARED BY CARDIAC SERVICE. ON FEBRUARY 27, 2023, ORTHOFIX SRL RECEIVED COPIES OF THE X-RAY IMAGES. ON MARCH 1, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: - THE DATE OF THE STRUTS FAILURE WAS (B)(6) 2023. - PATIENT WAS NOT AWARE OF EXACT TIME OF FAILURE OF THE 4 TL EVO STRUTS. - THE DATE OF THE STRUTS REPLACEMENT WITH THE 6 RAPID STRUTS WAS (B)(6) 2023. - THE SMITH&NEPHEW PLATE WAS IMPLANTED AT THE SAME TIME OF THE TL EVO FRAME ((B)(6) 2022) AND S&N REP WAS NOTIFIED OF THE BENT PLATE. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2023-00003 AND 9680825-2023-00004 AND 9680825-2023-00005. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-886005 (QUANTITY 4) - (MFR REPORTS: 9680825-2023-00002 AND 9680825-2023-00003 AND 9680825-2023-00004 AND 9680825-2023-00005). - HOSPITAL NAME: (B)(6) HOSPITAL. - SURGEON'S NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023. - BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 57 YEARS, MALE, 300 LB, IN POOR HEALTH CONDITION. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - EVENT DESCRIPTION: "EVO RINGS AND FOOTPLATE APPLIED FOR ANKLE FRACTURE. 4 LONG STRUTS WITH DYNA WERE USED. SMITH AND NEPHEW TUBULAR PLATE USED ON FIBULA. PATIENT WAS ADMITTED TO THE HOSPITAL IMMEDIATELY POST SURGERY DUE TO AN UNDERLYING HEART CONDITION. PATIENT IS FROM A CORRECTIONAL FACILITY AND HAS TWO 24/7 OFFICERS STATIONED WITH HIM AT ALL TIMES. DR (B)(6) RECEIVED NOTICE FROM THE FLOOR NURSE THAT HIS STRUT WAS BROKEN. DR (B)(6) , THE ORTHO RESIDENT AND MYSELF WENT TO THE PATIENTS ROOM TO FIND THAT ALL FOUR STRUTS WERE BROKEN IN HALF. ALL STRUTS WERE REMOVED AND 6 RAPID ADJUST STRUTS WERE APPLIED TO THE FRAME. XRAYS REVELED THAT THE SN PLATE WAS BROKEN IN HALF AND THE ANKLE SUBLUXED. THE PATIENT IS AWAITING HEART SURGERY BEFORE HE CAN RETURN TO THE OR UNDER ORTHOPAEDIC SERVICE. HE WAS SCHEDULED TO HAVE AN AHN ON (B)(6) 2023 DUE TO SUBLUXATION. THE SURGERY WAS CANCELED BY ANETHESIA DUE TO HIS HEART. THE PATIENT CLAIMS "THEY JUST BROKE WHEN I WAS LAYING IN BED". HE DENYS WALKING OR FALLING. THE CORRECTIONAL OFFICERS CLAIM NO KNOWLEDGE OF ANY INCIDENT." THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION AND LOSS OF ACHIEVED CORRECTION). - 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. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. - PATIENT CURRENT HEALTH CONDITION: CURRENTLY AWAITING BYPASS SURGERY. HIS CURRENT HEART CONDITION PREVENTS HIM FROM HAVING ANY ORTHOPAEDIC SURGERY TO CORRECT THE SUBLUXATION OF THE ANKLE. DR (B)(6) PLAN IS TO FUSE THE ANKLE WITH AHN ONCE THE PATIENT IS CLEARED BY CARDIAC SERVICE. ON FEBRUARY 27, 2023, ORTHOFIX SRL RECEIVED COPIES OF THE X-RAY IMAGES. ON MARCH 1, 2023, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: - THE DATE OF THE STRUTS FAILURE WAS (B)(6). - PATIENT WAS NOT AWARE OF EXACT TIME OF FAILURE OF THE 4 TL EVO STRUTS. - THE DATE OF THE STRUTS REPLACEMENT WITH THE 6 RAPID STRUTS WAS (B)(6) 2023. - THE SMITH&NEPHEW PLATE WAS IMPLANTED AT THE SAME TIME OF THE TL EVO FRAME ((B)(6) 2022) AND S&N REP WAS NOTIFIED OF THE BENT PLATE. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2023-00003 AND 9680825-2023-00004 AND 9680825-2023-00005. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716911 | TRUELOK EVO RX STRUT LONG WITH DYNA STERILE | TRUELOK EVO RX STRUT LONG WITH DYNA STERILE | KTT | ORTHOFIX SRL | B1693140R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |