STRUT TL-HEX
Report
- Report Number
- 9680825-2020-00025
- Event Type
- Injury
- Date Received
- March 10, 2020
- Report Date
- April 6, 2020
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K170650
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS. 1). COMPLAINT NUMBER(B)(4). (MFR REPORT 9680825-2020-00023): ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE CODE 50-10400 LOT NUMBER B1390276 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2019, WAS COMPRISED OF 61 UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATION HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. 2). COMPLAINTS NUMBER (B)(4). (MFR REPORTS 9680825-2020-00024 AND 9680825-2020-00025): THE DEVICE INVOLVED IN THESE EVENTS WAS DISCARDED BY THE HOSPITAL. UNFORTUNATELY ALSO THE DEVICE CODE AND THE LOT NUMBER HAVE NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION 1). COMPLAINT NUMBER (B)(4). (MFR REPORT 9680825-2020-00023): THE RETURNED DEVICE, RECEIVED ON MARCH 17, 2020, WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE RETURNED STRUT WAS SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: THE INNER BUSHING IS NOW MISSING FROM THE DEVICE. AS A REPLACEMENT, A PIECE OF TAPE WAS USED TO HOLD THE STUD IN PLACE. IT WAS ALSO EVIDENCED PRESENCE OF GLUE RESIDUALS IN CORRESPONDENCE OF THE THREADED PARTS OF THE OUTER TUBE. THIS CONFIRMS THAT THE GLUING ACTIVITIES WERE PROPERLY PERFORMED. THE DIMENSIONAL CHECK OF THE INTERNAL THREADS OF THE OUTER TUBE WAS DONE USING THE PROPER GAUGE SC2685 AND IT WAS FOUND TO BE CONFORMING TO SPECIFICATION. A DIMENSIONAL CHECK OF THE INNER BUSHING WAS NOT POSSIBLE AS IT WAS NOT RETURNED. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE RETURNED DEVICE IS NOT COMPLETE AND THEREFORE NOT FUNCTIONAL. 2). COMPLAINTS NUMBER (B)(4). (MFR REPORTS 9680825-2020-00024 AND 9680825-2020-00025): A TECHNICAL EVALUATION OF THE DEVICES INVOLVED IN THE EVENTS 2020040 AND 2020041 WAS NOT POSSIBLE AS THE DEVICES WERE DISCARDED BY THE HOSPITAL AND THEREFORE NOT AVAILABLE. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE EVENTS TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION, PERFORMED ON THE RETURNED DEVICE, WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. (B)(6) 2020: "RESITING THE DISTAL RING MEANS REPOSITIONING THE RING. I THINK THAT THIS MUST BE MORE THAN JUST A STRUT EXCHANGE. TO REPOSITION A TL-HEX RING I SUGGEST THE SURGEON NEEDS TO ENTER A NEW COMPUTER PROGRAMME THAT WILL ALLOW FOR THE CHANGED POSITION OF THE FAULTY STRUT. IT DOES SEEM THAT THEY HAVE A PROBLEM WITH THE STRUTS AT THIS PARTICULAR HOSPITAL. ONLY MINIMAL MOVEMENT BEING POSSIBLE IN THIS SITUATION IF ONE STRUT IS AFFECTED. WE NEED MORE SPECIFIC DETAILS". (B)(6) 2020 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "REGARDING THIS TECHNICAL REPORT, WE CAN NOTE THAT THE BLACK BUSHING THAT HELD THE STUD IN PLACE IS MISSING, AND THAT THE REST OF THE STRUT IS FULLY TO SPECIFICATION. THE CAUSE OF THIS EVENT IS INDEED UNKNOWN". CONCLUSION. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATION. THE FAILURE OCCURRED COULD BE ATTRIBUTABLE TO FORCING OF THE BLACK CAP DURING REPEATED REPROCESSING ACTIVITIES. PLEASE BE INFORMED THAT THE INSTRUCTIONS FOR USE OF THE PRODUCT STATES THAT "STRUTS AND RINGS SHOULD NOT BE DISASSEMBLED FOR CLEANING" (REF. PQTLH). A COMPLETE MEDICAL EVALUATION WAS NOT POSSIBLE AS NO INFORMATION ABOUT PATIENTS CONDITIONS, MEDICAL PROCEDURES, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. BASED ON THE INFORMATION AVAILABLE ON THE EVENTS, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENTS NOTIFIED. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOT. IN CASE FURTHER INFORMATION AND/OR THE DEVICES USED IN THE EVENTS (B)(4). ARE PROVIDED, ORTHOFIX SRL WILL PROMPTLY RE-OPEN THE INVESTIGATIONS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2020-00023 AND 9680825-2020-00024.
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: "MR. WILL EARDLEY HAS HAD THE BELOW ISSUE THREE TIMES IN THE PAST FEW WEEKS. ALL WITH DIFFERENT PATIENTS AND ALL HAVE CAUSED THE FRAMES TO MOVE POSITION SLIGHTLY. THE SMALL BLACK DISC ON THE STRUTS HAVE ALL UNSCREWED AND HAVE BEEN LOST". (ORTHOFIX SRL REF: 2020039 AND 2020040 AND 2020041 - MFR REPORTS NUMBER 9680825-2020-00023 AND 9680825-2020-00024 AND 9680825-2020-025). ON (B)(6) 2020, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE TERRITORY MANAGER AGAINST THE REQUEST TO RECEIVE A COMPLETED COMPLAINT FORM, ONE FOR EACH PATIENT, FOR THE THREE EVENTS OCCURRED WITH MR (B)(6). "I HAVE SPOKEN TO MR. (B)(6) AND UNFORTUNATELY HE CAN'T PROVIDE ENOUGH INFORMATION TO COMPLETE THE COMPLAINT FORMS. HE INFORMED ME THAT IT HAS HAPPENED 3 OR 4 TIMES BUT COULDN'T TRACE BACK THE PATIENTS INFORMATION, INITIAL SURGERY DATES, ANY DELAYS, WHEN THE FAULT OCCURRED ETC. HE DOES FRAMES IN SUCH HIGH NUMBERS AND SEES SO MANY IN CLINIC THAT THESE DETAILS SIMPLY AREN'T AVAILABLE. I CAN COMPLETE A COMPLAINT FORM FOR THE IMPLANT THAT I HAVE IN MY POSSESSION BUT UNFORTUNATELY COULD NOT COMPLETE A SECOND FORM". ON (B)(6) 2020, ORTHOFIX SRL RECEIVED THE FOLLOWING INFORMATION INCLUDED IN A COMPLAINT REPORT FORM (INFORMATION RELATED TO THE EVENT NUMBER 2020039 BUT APPLICABLE ALSO TO THE EVENTS 2020040 AND 2020041 APART FROM THE CODE AND LOT NUMBER OF THE STRUT CONCERNED): PRODUCT CODE: 50-10400 (LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1390276. HOSPITAL NAME: (B)(6) HOSPITAL SURGEON'S NAME: MR. (B)(6). DATE OF INITIAL SURGERY: UNKNOWN. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIAL TL-HEX FRAME. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THE SMALL BLACK DISC WHICH IS AT THE BACK OF THE HEAD OF THE TL-HEX STRUT BECOME LOOSE AND DETACHED FROM THE STRUT POST OP. THIS HAPPENED AROUND TWO WEEKS AFTER THE PATIENT HAD RETURNED HOME. THIS ENABLE THE STRUT TO MOVE ALTERING THE POSITION OF THE FRAME. A STRUT EXCHANGE NEEDED TO BE CARRIED OUT". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (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 NOT REQUIRED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED IN DATE NOT AVAILABLE) COPIES OF THE OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE PRODUCT IS AVAILABLE FOR RETURN. INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION IS NOT AVAILABLE NOTE AND COMMENTS FROM THE TERRITORY MANAGER: BELOW I HAVE INCLUDED DETAILS PROVIDED IN AN EMAIL FROM MR. (B)(6). "ESSENTIALLY ON AT LEAST THREE OCCASIONS PATIENTS HAVE COME BACK 'WITH A LOOSE STRUT'. ON LOOKING AT THE FRAME THE STRUT IS STILL HELD IN THE HOLE BY THE GRUB SCREW BUT THE STRUT HEAD TELESCOPES WITHIN THE HOUSING AS THE BLACK DISC IS NO LONGER THERE. TWO OF THESE REQUIRED A RESITING OF THE DISTAL RING. THE ISSUE IS HOWEVER THAT THESE ARE OFTEN INCREDIBLY NON COMPLIANT PATIENTS AND THERE ARE MANY, MANY VARIABLES THAT CAN INFLUENCE THE OVERALL LONGEVITY OF THE FRAME. SO ITS IMPOSSIBLE TO TRACE BUT ITS HAPPENING". MANUFACTURER REF: (B)(4).
ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THE EVENT (B)(4) WAS DISCARDED BY THE USER. UNFORTUNATELY ALSO THE DEVICE CODE AND LOT NUMBER HAVE NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE STRUT USED IN THE EVENT (B)(4) WILL NOT BE POSSIBLE AS THE DEVICE WAS DISCARDED BY THE USER AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THESE EVENTS WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2020-00023 AND 9680825-2020-00024.
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: "MR. (B)(6) HAS HAD THE BELOW ISSUE THREE TIMES IN THE PAST FEW WEEKS. ALL WITH DIFFERENT PATIENTS AND ALL HAVE CAUSED THE FRAMES TO MOVE POSITION SLIGHTLY. THE SMALL BLACK DISC ON THE STRUTS HAVE ALL UNSCREWED AND HAVE BEEN LOST". (ORTHOFIX (B)(4) REF: (B)(6) - MFR REPORTS NUMBER 9680825-2020-00023 AND 9680825-2020-00024). ON (B)(6) 2020, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE TERRITORY MANAGER: "I HAVE SPOKEN TO MR. (B)(6) AND UNFORTUNATELY HE CAN'T PROVIDE ENOUGH INFORMATION TO COMPLETE THE COMPLAINT FORMS. HE INFORMED ME THAT IT HAS HAPPENED 3 OR 4 TIMES BUT COULDN'T TRACE BACK THE PATIENTS INFORMATION, INITIAL SURGERY DATES, ANY DELAYS, WHEN THE FAULT OCCURRED ETC. HE DOES FRAMES IN SUCH HIGH NUMBERS AND SEES SO MANY IN CLINIC THAT THESE DETAILS SIMPLY AREN'T AVAILABLE. I CAN COMPLETE A COMPLAINT FORM FOR THE IMPLANT THAT I HAVE IN MY POSSESSION BUT UNFORTUNATELY COULD NOT COMPLETE A SECOND FORM". ON (B)(6) 2020, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING INFORMATION INCLUDED IN A COMPLAINT REPORT FORM (INFORMATION RELATED TO THE EVENT NUMBER (B)(4) BUT APPLICABLE ALSO TO THE EVENTS (B)(4) APART FROM THE CODE AND LOT NUMBER OF THE STRUT CONCERNED): PRODUCT CODE: 50-10400 (LONG STRUT TL-HEX - 158MM-318MM). BATCH NUMBER: B1390276. QUANTITY: 1. HOSPITAL NAME: (B)(6). SURGEON'S NAME: MR. (B)(6). DATE OF INITIAL SURGERY: UNKNOWN. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIAL TL-HEX FRAME. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: UNKNOWN. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "THE SMALL BLACK DISC WHICH IS AT THE BACK OF THE HEAD OF THE TL-HEX STRUT BECOME LOOSE AND DETACHED FROM THE STRUT POST OP. THIS HAPPENED AROUND TWO WEEKS AFTER THE PATIENT HAD RETURNED HOME. THIS ENABLE THE STRUT TO MOVE ALTERING THE POSITION OF THE FRAME. A STRUT EXCHANGE NEEDED TO BE CARRIED OUT". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (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 NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED IN DATE NOT AVAILABLE). COPIES OF THE OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION IS NOT AVAILABLE. NOTE AND COMMENTS FROM THE TERRITORY MANAGER: BELOW I HAVE INCLUDED DETAILS PROVIDED IN AN EMAIL FROM MR. (B)(6). "ESSENTIALLY ON AT LEAST THREE OCCASIONS PATIENTS HAVE COME BACK 'WITH A LOOSE STRUT'. ON LOOKING AT THE FRAME THE STRUT IS STILL HELD IN THE HOLE BY THE GRUB SCREW BUT THE STRUT HEAD TELESCOPES WITHIN THE HOUSING AS THE BLACK DISC IS NO LONGER THERE. TWO OF THESE REQUIRED A RESITING OF THE DISTAL RING. THE ISSUE IS HOWEVER THAT THESE ARE OFTEN INCREDIBLY NON COMPLIANT PATIENTS AND THERE ARE MANY, MANY VARIABLES THAT CAN INFLUENCE THE OVERALL LONGEVITY OF THE FRAME. SO ITS IMPOSSIBLE TO TRACE BUT ITS HAPPENING". MANUFACTURER REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273764 | STRUT TL-HEX | STRUT TL-HEX | KTT | ORTHOFIX SRL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |