MONOBLOC REAMER D. 8.0 MM L. 475 MM
Report
- Report Number
- 9680825-2021-00035
- Event Type
- Injury
- Date Received
- May 3, 2021
- Date of Event
- March 25, 2021
- Report Date
- August 13, 2021
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HTO
- UDI-DI
- 18032937169900
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 172080 BATCH V1353128 (LOT 6432520001 LASER MARKED ON COMPONENT) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF 16 DEVICES. 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, RECEIVED ON 4TH JUNE 2021, WAS SENT TO ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT FOR THE TECHNICAL EVALUATION. THE RETURNED DEVICE WAS SUBJECTED TO VISUAL CHECK AS PER ORTHOFIX SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: THE DEVICE IS BROKEN. ON THE REAMER'S SHAFT WERE EVIDENCED SCRATCHES AND THE SURFACE HAS ALSO TRACES OF RUST. THE DIMENSIONAL CHECK PERFORMED WHERE POSSIBLE DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE DEVICE IS BROKEN. THE CHECK OF THE RAW MATERIAL CERTIFICATES DID NOT SHOW ANY ANOMALIES. MEDICAL EVALUATION. THE INFORMATION MADE AVAILABLE ON THE EVENT TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. 28 APRIL 2021. IN THIS REPORT FROM FRANCE A BOY OF 14 YEARS HAD A FRACTURED LEFT TIBIA AND WAS BEING TREATED WITH AN INTRAMEDULLARY DEVICE. THE 8 MM MONOBLOC REAMER WAS USED BUT IT BROKE UP INSIDE THE PATIENT. IT WAS NECESSARY TO LEAVE 3 FRAGMENTS BEHIND IN THE PATIENT, 1 DISTAL AND 2 PROXIMAL. IT IS NOT CLEAR FROM THE REPORT WHAT HAPPENED NEXT. ADDITIONAL SURGERY WAS NOT REQUIRED, AND FURTHER MEDICAL INTERVENTION WAS NOT REQUIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ONE VERY IMPORTANT PIECE OF INFORMATION IS THAT THIS REAMER HAS BEEN STERILISED IN THIS HOSPITAL A TOTAL OF 92 TIMES, SO IT HAS BEEN SUBJECT TO A LOT OF WEAR. THE REAMING INSTRUMENTS ARE REUSABLE, USUALLY AS HERE FOR MANY TIMES. THEY UNDERGO MAXIMUM LOADING ONLY WHEN INSIDE A PATIENT'S BONE. THEY WILL BE INSPECTED AT THE END OF EACH OPERATION, BUT SIGNS OF WEAR MAY BE DIFFICULT TO ASCERTAIN. 6 AUGUST 2021: THIS TECHNICAL ANALYSIS CONFIRMS OUR INITIAL IMPRESSION THAT THIS MONOBLOC 8 MM REAMER BROKE AFTER MANY USES FROM WEAR AND TEAR AT THE END OF ITS MECHANICAL LIFE. AS STATED BEFORE, THESE INSTRUMENTS ARE SUBJECT TO MAXIMUM LOADING ONLY WHILE IN USE INSIDE THE PATIENT, AND IT IS IMPOSSIBLE TO ANTICIPATE EXACTLY WHEN FAILURE IS LIKELY TO HAPPEN. I FULLY AGREE WITH THE CONCLUSIONS OF THE TECHNICAL ANALYSIS. FINAL COMMENTS. THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATION. THE BREAKAGE OCCURRED IS ATTRIBUTABLE TO END OF LIFE FROM REPEATED USE AS IT HAS EXPERIENCED APPROXIMATELY EIGHT (8) YEARS OF USE. 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 172080 BATCH V1353128 (LOT 6432520001 LASER MARKED ON COMPONENT) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF 16 DEVICES. 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 TECHNICAL EVALUATION ON THE RETURNED DEVICE, RECEIVED AT ORTHOFIX SRL ON JUNE 4, 2021, IS CURRENTLY ON GOING. 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.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 14 YEAR-OLD. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: A 14-YEAR-OLD PATIENT UNDERWENT SURGERY FOR A FRACTURE OF THE LEFT TIBIA USING CENTROMEDULLARY NAILING. INTRAOPERATIVELY, INTRODUCTION WITH DIFFICULTY OF A FIRST 8.0 MM DIAMETER REAMER WHOSE DISTAL END BROKE INTO SEVERAL PIECES AND WHOSE DEBRIS REMAINED IMPLANTED IN THE PATIENT'S BONE. THREE PIECES OF METAL DEBRIS REMAINED IMPLANTED IN THE PATIENT'S TIBIA: 1 AT THE LOWER TIBIA AND 2 AT THE JOINT ENTRANCE. CURRENTLY, NO ADDITIONAL SURGERY WAS PERFORMED BUT IT IS POSSIBLE THAT A RE-INTERVENTION WILL BE PERFORMED TO RETRIEVE THE DEBRIS DEPENDING ON THE PROGRESS OF THE HEALING. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: UNIDENTIFIED DELAY. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: UNKNOWN. NOTE AND COMMENTS: RESIDUAL PIECES OF THE DEVICE WERE RETAINED FOR EXPERTISE. ACCORDING TO OUR FACILITY'S STERILIZATION TRACEABILITY DATA, THIS REAMER HAS UNDERGONE 92 STERILIZATIONS SINCE 15/08/2012. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON MAY 18, 2021: COPY OF X-RAY IMAGES. EXTRA TIME NEEDED TO FINALIZE THE SURGICAL PROCEDURE: LESS THAN 30 MIN. MANUFACTURER REF: 2021074. DISTRIBUTOR REF: CF 69.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: 14 YEAR-OLD. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: A 14-YEAR-OLD PATIENT UNDERWENT SURGERY FOR A FRACTURE OF THE LEFT TIBIA USING CENTROMEDULLARY NAILING. INTRAOPERATIVELY, INTRODUCTION WITH DIFFICULTY OF A FIRST 8.0 MM DIAMETER REAMER WHOSE DISTAL END BROKE INTO SEVERAL PIECES AND WHOSE DEBRIS REMAINED IMPLANTED IN THE PATIENT'S BONE. THREE PIECES OF METAL DEBRIS REMAINED IMPLANTED IN THE PATIENT'S TIBIA: 1 AT THE LOWER TIBIA AND 2 AT THE JOINT ENTRANCE. CURRENTLY, NO ADDITIONAL SURGERY WAS PERFORMED BUT IT IS POSSIBLE THAT A RE-INTERVENTION WILL BE PERFORMED TO RETRIEVE THE DEBRIS DEPENDING ON THE PROGRESS OF THE HEALING. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: UNIDENTIFIED DELAY. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: UNKNOWN. NOTE AND COMMENTS: RESIDUAL PIECES OF THE DEVICE WERE RETAINED FOR EXPERTISE. ACCORDING TO OUR FACILITY'S STERILIZATION TRACEABILITY DATA, THIS REAMER HAS UNDERGONE 92 STERILIZATIONS SINCE (B)(6) 2012. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON MAY 18, 2021: COPY OF X-RAY IMAGES. EXTRA TIME NEEDED TO FINALIZE THE SURGICAL PROCEDURE: LESS THAN 30 MIN. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 172080 BATCH V1353128 (LOT 6432520001 LASER MARKED ON COMPONENT) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF (B)(4) DEVICES. 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 CODE. TECHNICAL EVALUATION: THE INVOLVED DEVICE HAS NOT BEEN RETURNED TO ORTHOFIX SRL YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE IS RECEIVED. 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.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: LEFT TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6) YEAR-OLD. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: A (B)(6)-YEAR-OLD PATIENT UNDERWENT SURGERY FOR A FRACTURE OF THE LEFT TIBIA USING CENTROMEDULLARY NAILING. INTRAOPERATIVELY, INTRODUCTION WITH DIFFICULTY OF A FIRST 8.0 MM DIAMETER REAMER WHOSE DISTAL END BROKE INTO SEVERAL PIECES AND WHOSE DEBRIS REMAINED IMPLANTED IN THE PATIENT'S BONE. THREE PIECES OF METAL DEBRIS REMAINED IMPLANTED IN THE PATIENT'S TIBIA: 1 AT THE LOWER TIBIA AND 2 AT THE JOINT ENTRANCE. CURRENTLY, NO ADDITIONAL SURGERY WAS PERFORMED BUT IT IS POSSIBLE THAT A RE-INTERVENTION WILL BE PERFORMED TO RETRIEVE THE DEBRIS DEPENDING ON THE PROGRESS OF THE HEALING. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: UNIDENTIFIED DELAY. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPY OF OPERATIVE REPORTS AND X-RAY IMAGES ARE NOT AVAILABLE. PATIENT'S CURRENT HEALTH CONDITION: UNKNOWN. NOTE AND COMMENTS: RESIDUAL PIECES OF THE DEVICE WERE RETAINED FOR EXPERTISE. ACCORDING TO OUR FACILITY'S STERILIZATION TRACEABILITY DATA, THIS REAMER HAS UNDERGONE 92 STERILIZATIONS SINCE 15/08/2012. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656186 | MONOBLOC REAMER D. 8.0 MM L. 475 MM | MONOBLOC REAMER D. 8.0 MM L. 475 MM | HTO | ORTHOFIX SRL | V1353128 | 18032937169900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |