FITBONE SUBCUTANEOUS ENERGY RECEIVER
Report
- Report Number
- 9680825-2023-00032
- Event Type
- Injury
- Date Received
- August 2, 2023
- Date of Event
- July 20, 2023
- Report Date
- November 7, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- PMA / PMN Number
- K203399
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- 003
Narratives
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 NAIL CODE 60001445 INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH (MFR REPORT 9680825-2023-00031). THE RECEIVER CODE 600014780 INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOFIX. TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICES CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. IN ORDER TO PERFORM THE FAILURE INVESTIGATION, ORTHOFIX HAS REQUESTED THE COMPLAINANT TO PROVIDE AS FOLLOWS: DEVICES RETURNING FOR THE TECHNICAL ANALYSIS. PATIENT SEX AND WEIGHT. INFORMATION ABOUT THE FUNCTIONALITY TEST TO BE PERFORMED BOTH PRIOR TO AND AFTER IMPLANTING ON THE NAIL AND RECEIVER. DATE OF THE DETECTION OF THIS ISSUE. CONFIRMATION IF THE MOTOR NOISE COULD BE HEARD AT ANY POINT AFTER THE FINAL INTRAOPERATIVE TEST. CONFIRMATION IF THE YELLOW YELLOW "TRANSMIT" LED ON THE CONTROL SET WAS SEEN FLASHING 5 TIMES WITHIN ONE SECOND AT ANY POINT AFTER THE FINAL INTRAOPERATIVE TEST. COPIES OF THE X-RAY IMAGES FOR THE MEDICAL EVALUATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.
ON (B)(6) 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 NAIL CODE: 60001445 INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH (MFR REPORT 9680825-2023-00031). THE RECEIVER CODE: 600014780 INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOFIX (MFR REPORT 9680825-2023-00032). TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON AUGUST 3, 2023, WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATION. 1) NAIL CODE: 60001445 (MFR REPORT 9680825-2023-00031). THE VISUAL CHECK OF THE NAIL EVIDENCED AS FOLLOWS: DEFORMATION OF THE BIPOLAR CONNECTOR; PRESENCE OF SCRATCHES ALONG DEVICE AXIS; PRESENCE OF DRILLING SIGNS IN CORRESPONDENCE OF THE DISTAL HOLE (I.E. AT THE TAIL LEFT); PRESENCE OF DAMAGING SIGNS BETWEEN THE TWO PROXIMAL HOLES (I.E. AT THE TAIL RIGHT). THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK EVIDENCED THAT THE CURRENT ABSORBED AT THE MOTOR POLES IS ZERO, HIGHLIGHTING AN OPEN CIRCUIT DUE TO WIRE BREAKAGE. CONVERSELY, EVEN IF THE BIPOLAR CONNECTOR LOOKED SLIGHTLY DEFORMED, THE EXPECTED RESISTANCE WAS MEASURED, CONCLUDING THAT THE REASON OF THE FAILURE IS ASCRIBABLE TO THE MOTOR. THE DEVICE HAS BEEN SUBJECTED TO CT SCANNING, FOR INVESTIGATING THE FAILURE MORE IN DETAIL. THE TEST REVEALED THE BREAKAGE ON ONE OF THE SEVEN BOTTOM WIRES THAT CONNECT TO MOTOR COILS. 2) RECEIVER CODE: 60001780 (MFR REPORT 9680825-2023-00032). THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES: THE CABLE HAS NO BENDING OR OTHER DEFORMATIONS. THE SILICONE HAS NO DEFECTS, WEAR, OR SIGNS OF DAMAGE. THE SOCKET IS IN GOOD CONDITIONS (SOLDERING STILL INTACT). SCREWS WERE UNSCREWED TO SEPARATE THE RECEIVER FROM NAIL BIPOLAR CONNECTOR. RESIDUES OF ORGANIC TISSUE WERE DETECTED IN THE SOCKET. IN THE FUNCTIONAL CHECK THE DEVICE WAS TESTED WITH DIFFERENT LOADS, AT DIFFERENT DISTANCES AND IN DISTRACTION/RETRACTION MODE. NO ANOMALIES WERE DETECTED. THE DEVICE IS FUNCTIONING AS EXPECTED. MEDICAL EVALUATION: A MEDICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAY IMAGES HAVE BEEN MADE AVAILABLE. CONCLUSIONS: 1) NAIL CODE: 60001445 (MFR REPORT 9680825-2023-00031). THE ANALYSIS PERFORMED ON THE RETURNED NAIL CONFIRMED THE NOTIFIED ISSUE. THE NAIL IS NOT FUNCTIONING ACCORDING TO SET SPECIFICATIONS AS THERE IS AN ELECTRICAL OPEN CIRCUIT DUE TO A WIRE DAMAGED IN THE MOTOR. 2) RECEIVER CODE: 60001780 (MFR REPORT 9680825-2023-00032). THE FUNCTIONAL CHECK PERFORMED DID NOT DETECT ANY MALFUNCTION ON THE RETURNED RECEIVER, WHICH PERFORMS PROPERLY ACCORDING TO THE SET ACCEPTANCE CRITERIA. THE REASON OF THE FITBONE FAILURE IS RELATED TO THE DAMAGE DETECTED ON THE NAIL MOST LIKELY DUE TO THE SPECIFIC APPLICATION.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODES: 60001445 AND 60001780 (MFR REPORT: 9680825-2023-00031). BATCH NUMBERS: 6216365 AND B3077839. QUANTITY: (B)(4) EACH. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 24 YEARS. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "FAILURE OF FITBONE TIBIAL NAIL TO LENGTHEN AFTER IMPLANTATION. PATIENT IS STABLE, SECOND SURGERY REQUIRED." 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: PERFORMED ON (B)(6) 2023. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF X-RAY IMAGES IS NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT'S CURRENT HEALTH CONDITION: "PATIENT STABLE ACCORDING TO THE REPORTER. SUCCESSFUL SECOND SURGERY, NAIL AND RECEIVER REPLACED." ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF: (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODES: 60001445 AND 60001780 (MFR REPORTS: 9680825-2023-00031 AND 9680825-2023-00032 RESPECTIVELY). BATCH NUMBERS: 6216365 AND B3077839. QUANTITY: (B)(4) EACH. HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: ON (B)(6) 2023. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 24 YEARS. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "FAILURE OF FITBONE TIBIAL NAIL TO LENGTHEN AFTER IMPLANTATION. PATIENT IS STABLE, SECOND SURGERY REQUIRED." 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: PERFORMED ON (B)(6) 2023. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. COPY OF X-RAY IMAGES IS NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT'S CURRENT HEALTH CONDITION: "PATIENT STABLE ACCORDING TO THE REPORTER. SUCCESSFUL SECOND SURGERY, NAIL AND RECEIVER REPLACED." REGARDING THIS EVENT, ORTHOFIX RECENTLY RECEIVED A SURGEON REPORT WITH THE FOLLOWING DETAILS: THIS PATIENT IS A 24YR OLD MALE (WEIGHT +-70KG) WITH A MALUNION OF HIS LEFT TIBIA WITH VALGUS AND SHORTENING. HE UNDERWENT A FITBONE INSERTION, OSTEOTOMY AND REALIGNMENT OF HIS LEFT TIBIA WITH THE INTENTION TO ALSO EQUALISE HIS LIMB LENGTHS. THE SURGERY WAS PERFORMED ON (B)(6) 2023 AND WAS UNEVENTFUL. THE NAIL WAS NOT TESTED BEFORE IMPLANTATION AND AFTER IMPLANTATION. THE ISSUE WAS DETECTED ON THE DISTRACTION DAY WHICH WAS ON (B)(6). ON THIS DAY THERE WAS ACTIVATION OF THE YELLOW LED LIGHTS BUT NO SOUND. THE CONTROL SET WAS EXCHANGED, WITH THE SAME RESULT. THE PATIENT WAS TAKEN BACK TO THEATRE ON (B)(6) 2023. INTRA-OPERATIVELY THE NAIL WAS TESTED AGAIN. THE RECEIVER WAS EXCHANGED, BUT HAD NO EFFECT. EVENTUALLY THE NAIL WAS EXCHANGED AND THE NEW NAIL THEN WORKED. THE PATIENT HAS NOW FINISHED HIS DISTRACTION AND IS HAPPY WITH THE RESULT. THE X-RAY IMAGES ARE NOT AVAILABLE. ORTHOFIX SRL REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695590 | FITBONE SUBCUTANEOUS ENERGY RECEIVER | FITBONE SUBCUTANEOUS ENERGY RECEIVER | HSB | ORTHOFIX SRL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male | Required Intervention |