LOCKING END CAP 5 MM
Report
- Report Number
- 9680825-2022-00019
- Event Type
- Injury
- Date Received
- October 6, 2022
- Date of Event
- September 20, 2022
- Report Date
- November 24, 2022
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- PMA / PMN Number
- K141571
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T770005 LOT B1662290 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021 WAS COMPRISED OF 40 UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. 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. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE INVESTIGATION ARE 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.
ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T770005 LOT B1662290 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021 WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE END CAP CODE 99-T774025 LOT I20100.701 MARKED ON THE COMPONENT, BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2020, WAS COMPRISED OF (B)(4)UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED REGARDING THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED ON 13TH OCTOBER 2022, WERE EXAMINED BY ORTHOFIX SRL QUALITY OPERATIONS DEPARTMENT. LOCKING END CAP 5 MM CODE 99-T770005 LOT B1662290. THE VISUAL CHECK EVIDENCED SIGNS OF USE, I.E., SCRATCHES, BOTH ON THE THREAD AND ON THE HEAD OF THE CAP. CODE REFERENCE AND LOT NUMBER ARE STILL WELL VISIBLE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. TITANIUM LOW PROFILE SCREW, D 5MM L 25MM CODE 99-T774025 LOT I20100.701 (NOT INVOLVED IN THE COMPLAINT, BUT RETURNED WITH THE END CAP). THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE THREAD IS SLIGHTLY WORN, AS EVIDENCE THAT THE SCREW WAS USED ON PATIENT. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. THERE SHOULD BE NO PERMANENT HARM FOR THE PATIENT. THIS TECHNICAL ANALYSIS SHOW THAT NO GREAT FORCE HAD BEEN APPLIED TO THE END CAP HEXAGON. I NOTE THAT THE END CAP IS DESIGNED TO LOCK THE DISTAL LOCKING SCREW. THERE IS NO SIGN ON THE RETURNED SCREW THAT IT HAS BEEN COMPRESSED BY THIS PROCESS. I FULLY AGREE THAT THE ONLY FEASIBLE REASON FOR THIS INCIDENT IS THAT THE END CAP WAS NOT TIGHTENED SUFFICIENTLY WHEN IT WAS INSERTED. AS STATED IN THE TECHNICAL ANALYSIS, THE END CAP MUST BE TIGHTENED SECURELY, TO LOCK THE DISTAL SCREW AND THE END CAP IN PLACE. FINAL COMMENTS: THE ANALYSIS PERFORMED ON THE RETURNED DEVICES CONFIRMED THAT THEY ARE IN CONFORMITY WITH ORTHOFIX TECHNICAL SPECIFICATIONS. THE DIMENSIONAL CHECK CONFIRMED THAT DIMENSIONS RELATED TO CAP COUPLING WITH THE IMPLANTED NAIL ARE IN CONFORMITY WITH SPECIFICATIONS. PLEASE FIND BELOW THE INSTRUCTIONS ON LOCKING END CAP INSERTION, INCLUDED IN THE OPERATIVE TECHNIQUE AH2001OPT - AHN REVISION NAIL, PAGE 20: "LOCKING END CAP INSERTION: SELECT THE APPROPRIATE LOCKING END CAP (0, 5, 10MM). UTILIZING THE 3.5MM CANNULATED HEX DRIVER (GP510) AND THE 1.8MM X 350MM GUIDE WIRE, INSERT THE LOCKING END CAP IN A CANNULATED FASHION. CONFIRM PLACEMENT WITH FLUOROSCOPY. NOTE: THE LOCKING END CAP IS REQUIRED TO LOCK THE LM CALCANEAL SCREW. TIGHTEN THE END CAP UNTIL SECURE IN PLACE. PRECAUTIONS: REFRAIN FROM LEAVING THE NAIL, IN COMBINATION WITH THE SELECTED LOCKING END CAP, PROMINENT ON THE PLANTAR ASPECT OF THE FOOT." FROM THE EVIDENCE COLLECTED, AND FROM THE OUTCOME OF THE TECHNICAL ANALYSIS, WHICH CONFIRMED THE CONFORMITY OF THE DEVICES TO ORTHOFIX SPECIFICATIONS, IT COULD BE SUGGESTED THAT THE FAILURE NOTIFIED IS LIKELY ATTRIBUTABLE TO SOME FACTORS RELATED TO THIS SPECIFIC APPLICATION. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED REGARDING THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2022. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT AND ANKLE. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 49 YEAR-OLD, FEMALE, WEIGHT 55 KG, HEIGHT 150 CM. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: OPERATION DONE ON (B)(6) 2022. A MONTH AFTER THE SURGERY, THE END CAP DISENGAGED FROM THE NAIL. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO 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) 2022. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF X-RAY IMAGES IS AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PATIENT IS DOING FINE. FURTHER INFORMATION RECEIVED ON 30 SEPTEMBER 2022 FROM THE LOCAL DISTRIBUTOR: PATIENT HAVE CHARCOT FOOT. PATIENT'S ANKLE HIND FOOT NAIL SURGERY WAS DONE ON (B)(6) 2022. PATIENT IS NON WEIGHT BEARING FROM (B)(6) 2022 TO (B)(6) 2022. PATIENT IS PARTIAL WEIGHT BEARING FROM (B)(6) 2022- (B)(6) 2022. SURGEON FOUND END CAP CAME OUT ON (B)(6) 2022. SURGEON DID A REVISION CASE TO REMOVE THE PROXIMAL TIBIAL SCREW AND THE END CAP ON (B)(6) 2022. (B)(4).
THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL, SINGAPORE. SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2022. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT AND ANKLE. SURGERY DESCRIPTION: CORRECTION. PATIENT'S INFORMATION: 49 YEAR-OLD, FEMALE, WEIGHT 55 KG, HEIGHT 150 CM. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: OPERATION DONE ON (B)(6) 2022. A MONTH AFTER THE SURGERY, THE END CAP DISENGAGED FROM THE NAIL. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO 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) 2022, A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED, COPY OF X-RAY IMAGES IS AVAILABLE, PATIENT CURRENT HEALTH CONDITION: PATIENT IS DOING FINE. FURTHER INFORMATION RECEIVED ON 30 SEPTEMBER 2022 FROM THE LOCAL DISTRIBUTOR: PATIENT HAVE CHARCOT FOOT. PATIENT'S ANKLE HIND FOOT NAIL SURGERY WAS DONE ON (B)(6) 2022. PATIENT IS NON WEIGHT BEARING FROM (B)(6) 2022 TO (B)(6) 2022. PATIENT IS PARTIAL WEIGHT BEARING FROM 07/09/22- 19/09/22. SURGEON FOUND END CAP CAME OUT ON (B)(6) 2022. SURGEON DID A REVISION CASE TO REMOVE THE PROXIMAL TIBIAL SCREW AND THE END CAP ON (B)(6) 2022. FURTHER INFORMATION RECEIVED ON 22 NOVEMBER 2022 FROM THE LOCAL DISTRIBUTOR: PATIENT IS OK NOW. INFORMED BY SURGEON, THE TREATMENT WAS SUCCESSFULLY ALTHOUGH WITHOUT THE END CAP AND THE PATIENT RECOVERED. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: EMAIL OF 29/09/2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2150042 | LOCKING END CAP 5 MM | LOCKING END CAP 5 MM | HSB | ORTHOFIX SRL | B1662290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |