FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245
Report
- Report Number
- 9680825-2023-00041
- Event Type
- Injury
- Date Received
- September 14, 2023
- Date of Event
- July 28, 2023
- Report Date
- December 12, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- PMA / PMN Number
- K163368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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. 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 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 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 60001404 INVOLVED IN THIS EVENT WAS MANUFACTURED BY WITTENSTEIN INTENS GMBH. IN RELATION TO THIS EVENT, ORTHOFIX RECEIVED ALSO A RECEIVER CODE 60001780, MANUFACTURED BY ORTHOFIX. TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON SEPTEMBER 20, 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 60001404 THE VISUAL CHECK OF THE NAIL EVIDENCED AS FOLLOWS: - DEFORMATION OF THE BIPOLAR CONNECTOR, ALSO A HOLE WAS FOUND. - PRESENCE OF SCRATCHES ALONG DEVICE AXIS - THE NAIL WAS RECEIVED TOTALLY RETRACTED THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES, APART FROM THE FACT THAT THE NAIL WAS RECEIVED OVER-RETRACTED. DURING THE FUNCTIONAL CHECK THE NAIL WAS ELONGATED EVIDENCING PRESENCE OF WEAR AND RESIDUALS IN THE ELONGATED PART. THIS SUGGESTS THAT THE NAIL HAS BEEN ELONGATED AND THEN RETRACTED DURING TREATMENT. THE TEST UNDER STATIC LOAD EVIDENCED THAT THE RETURNED NAIL NOW DOES NOT MEET THE EXPECTED SPECIFICATION. 2) RECEIVER CODE 60001780 THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES, APART FROM A LITTLE DEFORMATION OF THE CABLE. 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 THE INFORMATION MADE AVAILABLE ON THE EVENT WAS EVALUATED BY OUR MEDICAL DIRECTOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. "THE DEVICE HAD BEEN IMPLANTED FOR THE PURPOSE OF LEFT FEMORAL LENGTHENING IN A 33-YEAR-OLD FEMALE WHO SEEMINGLY HAD FAILED OTHER DEVICES. A SEQUENCE OF AP PLAIN RADIOGRAPHS WITH SCALING MARKERS ARE APPENDED TO THE FILE. INDEX SURGERY WAS ON THE 12TH JULY 2023. WITHOUT THE BENEFIT OF A LATERAL, THESE IMAGES REPRESENT A WELL-PLACED DEVICE ON AP AND DEMONSTRATE RETRACTION AND THEREBY FAILURE OF CONTINUED ELONGATION. FROM THE 21ST JULY 2023 TO THE 24TH JULY A GAP OF 5MM PERSISTED, AND THEREAFTER ON THE 28TH OF JULY IT HAD REDUCED TO 2MM (BACK TO WHAT IT HAD BEEN ON RADIOGRAPHS FROM THE 17TH JULY 2023). AT PRESENT, NEITHER THE FAILURE NOR THE SUBSEQUENT REVISION PROCEDURE HAVE RESULTED IN ANY OTHER DELETERIOUS SEQUALAE". CONCLUSIONS 1) NAIL CODE 60001404 THE ANALYSIS PERFORMED ON THE RETURNED NAIL CONFIRMED THE NOTIFIED ISSUE. THE NAIL IS NOT FUNCTIONING ACCORDING TO SET SPECIFICATIONS UNDER STATIC LOAD. WITH THE INFORMATION MADE AVAILABLE, IT IS NOT POSSIBLE TO DEFINE THE ROOT CAUSE OF THE PROBLEM OCCURRED, WHICH REMAINS UNKNOWN. 2) RECEIVER CODE 60001780 THE FUNCTIONAL CHECK PERFORMED DID NOT DETECT ANY MALFUNCTION ON THE RETURNED RECEIVER, WHICH PERFORMS PROPERLY ACCORDING TO THE SET ACCEPTANCE CRITERIA. ORTHOFIX CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION PROVIDED BY THE 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 LEFT. SURGERY DESCRIPTION: LENGTHENING. PATIENT INFORMATION: 33 YEARS, FEMALE, 49 KG, 156 CM. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. EVENT DESCRIPTION: "(B)(6) 2023: NO MOTOR NOISE, NO ENERGY TRANSFER POSSIBLE." 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: PERFORMED ON (B)(6) 2023. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT'S CURRENT HEALTH CONDITION: GOOD FUNCTION AFTER REPLACEMENT OF THE IMPLANT. ORTHOFIX SRL REF: (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: HERZOGPARK KLINIK - SURGEON'S NAME: PROF BAUMGART - DATE OF INITIAL SURGERY: (B)(6) 2023 - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR LEFT - SURGERY DESCRIPTION: LENGTHENING - PATIENT INFORMATION: 33 YEARS, FEMALE, 49 KG, 156 CM - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - EVENT DESCRIPTION: "(B)(6) 2023: NO MOTOR NOISE, NO ENERGY TRANSFER POSSIBLE" 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: PERFORMED ON (B)(6) 2023 - COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN - PATIENT'S CURRENT HEALTH CONDITION: GOOD FUNCTION AFTER REPLACEMENT OF THE IMPLANT. ORTHOFIX SRL REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2283437 | FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245 | FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245 | HSB | ORTHOFIX SRL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Required Intervention |