TRUE LOK PLUS SHORT QUICK ADJUST STRUT
Report
- Report Number
- 9680825-2024-00034
- Event Type
- Malfunction
- Date Received
- June 11, 2024
- Date of Event
- May 15, 2024
- Report Date
- July 25, 2024
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K170650
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170 LOT B3933659 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN YEAR 2023, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2024-00033) ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170 LOT B3974798 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN YEAR 2023, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICES WERE RECEIVED AT ORTHOFIX ON MAY 30, 2024. THE TECHNICAL EVALUATION IS ON GOING. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION ARE AVAILABLE, ORTHOFIX WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170 LOT B3933659 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN YEAR 2023, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2024-00033) ORTHOFIX CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170 LOT B3974798 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN YEAR 2023, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2024-00034) TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON MAY 30, 2024, WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE VISUAL CHECK EVIDENCED THE PRESENCE OF A BROKEN BOLT INSIDE THE FEMALE END PART (CORE BOLT) OF BOTH STRUTS. SLIGHT SIGNS WERE PRESENT ON THE EXTERNAL SURFACE OF BOTH STRUTS, CAUSED BY THE ATTEMPTED USE. FROM THE VISUAL CHECK, IT WAS POSSIBLE TO VERIFY THAT THE THREADS OF THE BROKEN BOLT WERE NOT ALIGNED WITH THE THREADS OF THE FEMALE END PART (CORE BOLT) OF BOTH STRUTS. SURFACE FRACTURE OF THE BOLT SUGGESTS THAT THE BREAKAGE OCCURRED DUE TO A TORSIONAL OVERLOAD. A DIMENSIONAL AND FUNCTIONAL CHECK WAS NOT POSSIBLE DUE TO THE PRESENCE OF A BROKEN BOLT IN BOTH STRUTS. CONCLUSIONS THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT BOTH THE RETURNED STRUTS ARE CONFORMING TO ORTHOFIX SPECIFICATIONS, AND THEY STILL FUNCTION AS EXPECTED. THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF AN EXCESSIVE TORQUE WHEN LOCKING THE DEVICE TO THE RING, WHICH BROKE THE LOCKING BOLTS THAT WERE ASSEMBLED NOT PROPERLY ALIGNED. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOT. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 50-10170 BATCH NUMBERS: B3933659 AND B3974798 (MFR REPORTS: 9680825-2024-00033) QUANTITY: 1. EACH HOSPITAL NAME: (B)(6) MEDICAL CENTER. SURGEON NAME: DR.(B)(6). DATE OF INITIAL SURGERY: (B)(6) 2024. BODY PART TO WHICH DEVICE WAS APPLIED: LOWER LEG SURGERY DESCRIPTION: FRACTURE TREATMENT PATIENT INFORMATION: 61 YEARS, MALE, 110 KG, 170 CM PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION: THE BOLT ON THE TL STRUT BROKE DURING APPLICATION OF THE STRUT. HAPPENED TWICE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE A REPLACEMENT DEVICE OF SAME MODEL WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: APPROXIMATELY 1 HOUR. TWO NEW STRUTS NEEDED TO ARRIVE, TOOK SOME TIME AN ADDITIONAL SURGERY WAS NOT REQUIRED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE PRODUCT IS AVAILABLE FOR RETURN PATIENT'S CURRENT HEALTH CONDITION: GOOD. ON JUNE 6, 2024, ORTHOFIX RECEIVED COPIES OF THE X-RAY IMAGES AND THE FOLLOWING DETAILS: THE PATIENT WAS UNDER ANAESTHETICS, DURING OPERATION. WE HAD TO GET "OTHER STRUTS" BEFORE WE GOOD CONTINUE ONBUILDING THE FRAME. FOR THE PATIENT ITSELF THIS IS NOT AN ISSUE. PATIENT IS DISCHARGED ACCORDING TO PLAN AND UNDER RECOVERY. OUT-PATIENT CLINIC FOLLOW-UP IS STILL IN PROGRESS. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 50-10170- BATCH NUMBERS: B3933659 AND B3974798 (MFR REPORTS: 9680825-2024-00033 AND 9680825-2024-00034). QUANTITY: 1 EACH, HOSPITAL NAME: (B)(6) MEDICAL CENTER, SURGEON NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2024, BODY PART TO WHICH DEVICE WAS APPLIED: LOWER LEG, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT INFORMATION: 61 YEARS, MALE, 110 KG, 170 CM, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: THE BOLT ON THE TL STRUT BROKE DURING APPLICATION OF THE STRUT. HAPPENED TWICE. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE OF SAME MODEL WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: APPROXIMATELY 1 HOUR. TWO NEW STRUTS NEEDED TO ARRIVE, TOOK SOME TIME. AN ADDITIONAL SURGERY WAS NOT REQUIRED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE PRODUCT IS AVAILABLE FOR RETURN PATIENT'S CURRENT HEALTH CONDITION: GOOD. ON (B)(6) 2024, ORTHOFIX RECEIVED COPIES OF THE X-RAY IMAGES AND THE FOLLOWING DETAILS: THE PATIENT WAS UNDER ANAESTHETICS, DURING OPERATION. WE HAD TO GET "OTHER STRUTS" BEFORE WE GOOD CONTINUE ON BUILDING THE FRAME. FOR THE PATIENT ITSELF THIS IS NOT AN ISSUE. PATIENT IS DISCHARGED ACCORDING TO PLAN AND UNDER RECOVERY. OUT-PATIENT CLINIC FOLLOW-UP IS STILL IN PROGRESS. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1295837 | TRUE LOK PLUS SHORT QUICK ADJUST STRUT | TRUE LOK PLUS SHORT QUICK ADJUST STRUT | KTT | ORTHOFIX SRL | B3974798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male |