FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200
Report
- Report Number
- 9680825-2023-00008
- Event Type
- Injury
- Date Received
- March 10, 2023
- Report Date
- June 27, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- PMA / PMN Number
- K203399
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
ON FEBRUARY 2023 ORTHOFIX SRL ACQUIRED FROM WITTGENSTEINIAN GMBH, THE FITBONE¿ SYSTEM, FOR INTRAMEDULLARY LENGTHENING OF THE FEMUR AND TIBIA. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR FITBONE DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY WITTGENSTEINIAN GMBH. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTGENSTEINIAN GMBH. TECHNICAL EVALUATION: DURING THE TECHNICAL INVESTIGATION IT WAS FOUND THAT THE PRODUCT INVOLVED IS NOT THE RECEIVER AS PREVIOUSLY COMMUNICATED (WHICH FUNCTIONED AS INTENDED), BUT THE NAIL REFERENCE CODE 60001921, WHICH WAS RETURNED FOR ANALYSIS OVER-RETRACTED. THE RETURNED DEVICES WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK. 1. NAIL CODE 60001921 S/N (B)(4). THE VISUAL CHECK EVIDENCED: - SCRATCHES ALONG DEVICE AXIS; - HIGH DEFORMATION OF THE DISTAL HOLE (TAIL LEFT) AND SLIGHT DEFORMATION OF THE PROXIMAL HOLES (TAIL RIGHT); - ABRASION NEAR THE PROXIMAL HOLES (I.E., ON THE MOTOR HOUSING, NEAR THE WELD WITH THE TAIL RIGHT). THE BIPOLAR CONNECTOR OF THE NAIL WAS NOT RETURNED FOR ANALYSIS. IT WAS PROBABLY REMOVED AND DISCARDED DURING NAIL EXPLANT. THE NAIL IS FULLY RETRACTED, AS THE TAIL LEFT AND THE TELESCOPIC TUBE LASER WELD ARE ONLY PARTIALLY VISIBLE. IN THE DIMENSIONAL CHECK THE EXPOSED DISTANCE OF THE LEFT TAIL WAS EVALUATED. THE MEASURED VALUE IS LOWER THAN THE SPECIFICATION AT WHICH THE NAIL SHALL BE BROUGHT FOR THE CLINICAL USE. THIS MEANS THAT THE NAIL HAS BEEN OVER-RETRACTED. A COMPLETE FUNCTIONAL CHECK (LOAD TEST) WAS NOT POSSIBLE, BECAUSE THE BIPOLAR CONNECTOR WAS NOT RETURNED. THE NAIL WAS THEN CUT TO ACCESS TO GEARMOTORS POLES: -THE SOLDERING JOINTS DID NOT EVIDENCE ANY ANOMALIES. IT IS CONFIRMED THAT THE BIPOLAR FEEDLINE WAS STRIPPED OFF. -THE TERMINAL RESISTANCE IS CONFORMING TO SPECIFICATIONS. -THE CHECK OF CURRENT ABSORPTION WITH NO LOAD IS NOT CONFORMING TO SPECIFICATIONS. WHEN THE VOLTAGE WAS APPLIED, THE MOTOR RAN SOME SECONDS BUT THEN BLOCKED, CONFIRMING AN ANOMALY IN DEVICE FUNCTIONING. THEREFORE, THE INTRAMEDULLARY LENGTHENING NAIL HAS BEEN SENT TO AN EXTERNAL LABORATORY FOR X-RAYS COMPUTED TOMOGRAPHY SCAN. THE IMAGES OBTAINED SHOWED THAT NO GAP IS ANYMORE PRESENT BETWEEN THE TELESCOPIC TUBE AND THE LEAD SCREW, SUGGESTING THAT THE DRIVE MECHANISMS JAMMED FOLLOWING AN EXCESSIVE RETRACTION. 2. RECEIVER CODE 60001780 S/N (B)(6) (RELEVANT ASSOCIATED DEVICE) THE VISUAL CHECK EVIDENCED THAT THE BIPOLAR CABLE IS DAMAGED, THE ENCAPSULATION BY SILICONE TUBE HAS BEEN COMPROMISED AND THE WIRES ARE DEFORMED AND DAMAGED. THIS DAMAGE WAS POSSIBLY CAUSED DURING EXPLANT. SIGNS OF DAMAGE ARE PRESENT ON RECEIVER SHELL AS WELL. NO OTHER ANOMALIES WERE DETECTED. THE FUNCTIONAL CHECK EVIDENCED THAT THE RECEIVER WAS NOT FUNCTIONING, POSSIBLY DUE TO THE DAMAGE OF THE BIPOLAR CABLE DURING EXTRACTION. THE CABLE WAS THEN CUT, TO ISOLATE THE TWO POLES. THE FUNCTIONAL TEST WAS PERFORMED AGAIN WITH POSITIVE OUTCOME, I.E., THE RECEIVER IS FUNCTIONING PROPERLY BOTH IN DISTRACTION AND IN RETRACTION MODE. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW A SUMMARY OF THE MEDICAL EVALUATION PERFORMED. -IT SEEMS THAT THIS FITBONE WAS BEING USED TO TRY TO ACHIEVE BONE TRANSPORT. THE NAIL WAS RETRACTED TO TRY TO RESTART THE LENGTHENING, BUT IT SEEMS THAT THE RETRACTION WAS EXCESSIVE, AND THE NAIL JAMMED. THE CONNECTING WIRE USED TO DRIVE THE MOTOR WAS DAMAGED WHEN RETURNED TO ORTHOFIX, BUT IT IS LIKELY THAT THIS WAS CAUSED BY DEVICE EXTRACTION. WHEN THE ENTIRE IMPLANT WAS EXCHANGED FOR A NEW ONE EVERYTHING WORKED AS EXPECTED. I AM HAPPY TO SUPPORT THE CONCLUSION OF THE TECHNICAL ANALYSIS. FINAL COMMENTS THE TECHNICAL ANALYSIS ON THE RETURNED DEVICES EVIDENCED: 1. NAIL CODE 60001921 S/N (B)(6). THE NAIL WAS NOT FUNCTIONING CORRECTLY. VISUAL INSPECTION AND CT SCANNING EVIDENCED THAT THE DEVICE WAS EXCESSIVELY RETRACTED. SINCE NO GAP WAS OBSERVED AT SPECIFIC POSITIONS BETWEEN THE TELESCOPIC TUBE AND THE LEAD SCREW BY SCANNING THE NAIL AXIALLY, A MECHANICAL JAMMING COULD BE SUGGESTED. ACCORDING TO THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER, IT COULD BE ASSUMED THAT SOME LOAD BEARING WAS APPLIED FOLLOWING THE NAIL MAXIMUM RETRACTION, LEADING TO THE FAILURE NOTIFIED. 2. RECEIVER CODE 60001780 S/N (B)(6). THE RECEIVER WAS RETURNED HEAVILY DAMAGED, WITH THE WIRES STRIPPED OFF AND WITH THE INSULATION BY SILICONE TUBE COMPROMISED. THE DAMAGE, MOST LIKELY OCCURRED DURING EXPLANT, COMPROMISED DEVICE FUNCTIONALITY. WHEN THE RECEIVER WAS PEELED OFF, TO ISOLATE THE TWO POLES, IT WAS CONFIRMED THAT THE ELECTRONICS FUNCTION PROPERLY, BOTH IN DISTRACTION AND IN RETRACTION MODE. FROM THE RESULTS OF THE TECHNICAL EVALUATION ORTHOFIX CAN CONCLUDE THAT THE FAILURE OCCURRED IS RELATED TO THE CONDITIONS OF USE OF THE DEVICE DURING THIS SPECIFIC APPLICATION, I.E., LOAD APPLIED WHILE THE NAIL WAS EXCESSIVELY RETRACTED. ORTHOFIX RECOMMENDS FOLLOWING THE INSTRUCTIONS INCLUDED IN THE RELEVANT INSTRUCTIONS FOR USE, IN SECTION PRECAUTIONS: 17. RETRACTION MUST NOT BE CARRIED OUT OVER THE INITIAL TOTAL LENGTH OF THE INTRAMEDULLARY LENGTHENING NAIL SINCE THIS MIGHT CAUSE JAMMING OF THE IMPLANT. DURING ENERGY TRANSMISSION, MONITOR THE RETRACTION WITH THE STETHOSCOPE AND CONTINUOUS X-RAY MONITORING. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ON FEBRUARY 2023 ORTHOFIX SRL ACQUIRED FROM WITTENSTEIN INTENS GMBH, THE FITBONE¿ SYSTEM, FOR INTRAMEDULLARY LENGTHENING OF THE FEMUR AND TIBIA. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR FITBONE DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY WITTENSTEIN INTENS GMBH. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES 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). - SURGEON'S NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2023. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: LENGTHENING. - PATIENT'S INFORMATION: MALE; PREVIOUS HEALTH CONDITION: FIRST SURGERY TO IMPLANT THE FITBONE NAIL WAS PERFORMED ON (B)(6) 2022 FOR LENGTHENING PURPOSE. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: THE 60001921 NAIL WAS IMPLANTED ON (B)(6) 2022 IN ORDER TO LENGTHEN THE BONE. THE NAIL AND THE REMOTE CONTROL WORKED PROPERLY BUT THE BONE GROWTH WAS NOT SATISFYING. A NEW SURGERY WAS PLANNED ON (B)(6) 2023 TO RETRACT THE FITBONE NAIL AND DO A BONE TRANSPLANT. AFTER THE SURGERY, WHEN THE PATIENT USED THE REMOTE TO LENGTHEN THE NAIL, IT DID A SMALL NOISE , THEN NOTHING HAPPENED. IT SEEMED THAT IT WAS NOT WORKING. SO THEY DECIDED TO OPERATE THE PATIENT AGAIN ON MARCH 1ST (TODAY). THEY CHANGED THE RECEIVER AND THE NAIL AND IMPLANTED NEW ONES. EVERYTHING WORKED PROPERLY. THE LENGTHENING WORKS. 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 REQUIRED: (B)(6) 2023. - COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. - COPY OF FINAL X-RAY IMAGES IS AVAILABLE. - PATIENT'S CURRENT HEALTH CONDITION: AFTER SURGERY TODAY THE PATIENT IS FINE. FURTHER INFORMATION RECEIVED FROM THE LOCAL DISTRIBUTOR: -PATIENT HEIGHT: 1.63. -WEIGHT: 97 KG. -ON THE LAST RADIO, EVERYTHING SEEMS FINE. THE SURGEON IS SEEING THE PATIENT AGAIN IN 2 WEEKS. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: LENGTHENING. PATIENT'S INFORMATION: MALE; PREVIOUS HEALTH CONDITION: FIRST SURGERY TO IMPLANT THE FITBONE NAIL WAS PERFORMED ON (B)(6) 2022 FOR LENGTHENING PURPOSE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: THE 60001921 NAIL WAS IMPLANTED ON (B)(6) 2022 IN ORDER TO LENGTHEN THE BONE. THE NAIL AND THE REMOTE CONTROL WORKED PROPERLY BUT THE BONE GROWTH WAS NOT SATISFYING. A NEW SURGERY WAS PLANNED ON (B)(6) 2023 TO RETRACT THE FITBONE NAIL AND DO A BONE TRANSPLANT. AFTER THE SURGERY, WHEN THE PATIENT USED THE REMOTE TO LENGTHEN THE NAIL, IT DID A SMALL NOISE, THEN NOTHING HAPPENED. IT SEEMED THAT IT WAS NOT WORKING. SO THEY DECIDED TO OPERATE THE PATIENT AGAIN ON (B)(6) (TODAY). THEY CHANGED THE RECEIVER AND THE NAIL AND IMPLANTED NEW ONES. EVERYTHING WORKED PROPERLY. THE LENGTHENING WORKS. 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 REQUIRED: (B)(6) 2023. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF FINAL X-RAY IMAGES IS AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: AFTER SURGERY TODAY THE PATIENT IS FINE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1201821 | FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200 | FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0940-F-200 | HSB | ORTHOFIX SRL | 60001921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |