ADV LRS KIT 300MM
Report
- Report Number
- 9680825-2024-00029
- Event Type
- Injury
- Date Received
- May 7, 2024
- Report Date
- July 8, 2024
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDW
- PMA / PMN Number
- K955848
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1082462 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017 WAS COMPRISED OF 5 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1543107 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2020 WAS COMPRISED OF 7 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RECEIVED BY ORTHOFIX SRL YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. AS SOON AS FURTHER INFORMATION IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2024-00028.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1082462 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017 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 FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE LOT B1543107 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2020 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 FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE DEVICES INVOLVED IN THIS EVENT WERE RECEIVED BY ORTHOFIX SRL ON 30 MAY 2024. THEY WERE THEN SENT TO AN EXTERNAL LABORATORY FOR DECONTAMINATION AND STERILIZATION ACTIVITIES AS THEY WERE RECEIVED IN CONTAMINATED CONDITIONS (DIRTY) AND THEREFORE NOT SAFE FOR HANDLING. AFTER THE RETURN OF THE INVOLVED DEVICES FROM THE EXTERNAL LABORATORY THEY WERE EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. 1) VISUAL EXAMINATION CODE 50009 LONG C/D CLICKER MODEL THE VISUAL EXAMINATION ON THE 2 LONG CLICKER BODY RETURNED DID NOT EVIDENCE ABNORMAL SIGNS ON THE SURFACE. THE HEXAGONS ARE IN GOOD CONDITION. CODE 53550 ADV LRS RAIL 300MM IN THE TWO RAILS IT WAS POSSIBLE TO SEE SIGNS DUE TO FORCING. MOREOVER, THERE ARE SPOTS/RESIDUES, WHICH COULD BE RELATED TO THE USE OF DETERGENTS DURING DECONTAMINATION, OR TO ORGANIC RESIDUES, NOT CLEANED SINCE THE DEVICES WERE RETURNED PARTIALLY ASSEMBLED. CLAMPS SIGNS OF DAMAGE WERE DETECTED ON THE COVER CLAMP (REF. CODE 53527) AND ON THE PLATFORM CONNECTION METAPHYSEAL RAIL CLAMP (REF. CODE 530501). MOREOVER, THERE ARE SPOTS/RESIDUES WHICH COULD BE RELATED TO THE USE OF DETERGENTS DURING DECONTAMINATION, OR TO ORGANIC RESIDUES, NOT CLEANED SINCE THE DEVICES WERE RETURNED PARTIALLY ASSEMBLED. ALL THE RETURNED SCREWS WERE IN GOOD CONDITION, DESPITE THE PRESENCE OF RESIDUES RELATED TO USE. A PORTION OF A DEVICE (POSSIBLY A BROKEN SCREW) WAS FOUND INSIDE ONE HOLE OF THE PLATFORM CONNECTION METAPHYSEAL RAIL CLAMP. IN ALL THE ITEMS REFERENCE CODE AND LOT NUMBER ARE STILL VISIBLE, BUT IN SOME CASES THE LASER MARKING IS SLIGHTLY FADED. 2) FUNCTIONAL CHECK: CODE 50009 LONG C/D CLICKER MODEL: THE TWO DEVICES HAVE BEEN CORRECTLY EXTENDED AND RETRACTED. DURING THIS OPERATION SOME DEBRIS CAME OUT OF THE ITEMS. THE BUTTONS FUNCTIONALITY WAS EVALUATED TOO. TEST PASSED. IT WAS POSSIBLE TO CORRECTLY DISASSEMBLE ALL THE DEVICES RETURNED. THE FUNCTIONAL CHECK CONFIRMED THAT THEY STILL PERFORM AS INTENDED. CONCLUSIONS: THE VISUAL INSPECTION DID NOT EVIDENCE ANY ISSUES ON THE RETURNED DEVICES, DESPITE SOME NORMAL SIGNS OF WEAR DUE TO USE. WHEN THE DEVICES WERE DISASSEMBLED, DEBRIS WAS FOUND, AND SOME SPOTS COULD BE EVIDENCED ON THE SURFACE. IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE RESIDUES. DURING THE FUNCTIONAL CHECK IT WAS CONFIRMED THAT ALL THE DEVICES RETURNED PERFORMED PROPERLY. ORTHOFIX WOULD LIKE TO CONFIRM THAT THE RETURNED DEVICES ARE MULTIPLE USE DEVICES AND CAN BE RE-USED FOLLOWING THE CORRECT PROCESS OF CLEANING/STERILIZATION/RE-STERILIZATION ACTIVITIES INCLUDED IN THE INSTRUCTIONS FOR USE OF THE ORTHOFIX RECONSTRUCTION SYSTEMS, RE. PQREC. REGARDING THE BIOCOMPATIBILITY, ORTHOFIX WOULD LIKE TO INFORM THAT THE INSTRUMENTS AND EXTERNAL FIXATION DEVICES BELONGING TO THE RECONSTRUCTION SYSTEMS ARE INTENDED TO BE USED ONLY IN CONNECTION WITH BODY CONTACTING INSTRUMENTS AND THERE IS NO INTENDED BODY CONTACT WITH THE PATIENT'S TISSUES, BUT ONLY WITH SURGEON'S GLOVED HANDS. FOR THIS REASON, ITEMS INVOLVED IN THIS NOTIFICATION WERE CATEGORIZED AS NON-CONTACTING DEVICES, ACCORDING TO ISO10993-1. FROM THE EVIDENCE COLLECTED, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE ISSUE OCCURRED, BUT IT CAN BE CONCLUDED THAT IT IS NOT RELATED TO THE PRODUCTS RETURNED. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2024-00028 FOLLOW UP 1.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: LENGTHENING. PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM. EVENT DESCRIPTION: THE PATIENT CLAIMS THAT HE EXPERIENCED COMPLICATIONS AFTER THE SURGERY, INFECTION AND LIMPNESS. 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 NOT REQUIRED A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE PATIENT CURRENT HEALTH CONDITION: N/A. PLEASE NOTE THE DEVICES WERE PROVIDED AND BROUGHT TO THE HOSPITAL BY THE SURGEON WHO DID THE SURGERY, AND THE SURGEON HAS CONFIRMED THAT THE DEVICE WAS USED ON ANOTHER PATIENT BEFORE. THE DEVICES HAVE ALREADY BEEN REMOVED FROM THE PATIENT AND ARE CURRENTLY AVAILABLE WITH THE PATIENT. NOTE BY THE LOCAL DISTRIBUTOR: ITEMS SOLD TO THE SURGEON ON 2021 AND IMPLANTED FOR THE FIRST TIME ON 2021, THE SURGEON REUSE THE IMPLANTS ON HIS OWN RESPONSIBILITY WITHOUT GETTING BACK TO US ON OTHER PATIENT AND THE COMPLAINT RAISED BY ANOTHER PATIENT IMPLANTED THE ITEMS ON 2022. THE PATIENT PLAN FOR LENGTHENING 6 CM, AFTER LENGTHENING OF 3.6 CM SUFFER FROM LIMPNESS AND INFECTION. ORTHOFIX SRL REF: (B)(4). DISTRIBUTOR REF: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2024-00028.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) MEDICAL CLINIC, SURGEON'S NAME: DR. (B)(6), DATE OF INITIAL SURGERY: ON (B)(6) 2021, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: LENGTHENING, PATIENT INFORMATION: N/A. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE TYPE OF PROBLEM: CLINICAL (PATIENT) PROBLEM EVENT DESCRIPTION: THE PATIENT CLAIMS THAT HE EXPERIENCED COMPLICATIONS AFTER THE SURGERY, INFECTION AND LIMPNESS. PLEASE NOTE THE DEVICES WERE PROVIDED AND BROUGHT TO THE HOSPITAL BY THE SURGEON WHO DID THE SURGERY, AND THE SURGEON HAS CONFIRMED THAT THE DEVICE WAS USED ON ANOTHER PATIENT BEFORE. 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 NOT REQUIRED, A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED, COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE, COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE, PATIENT CURRENT HEALTH CONDITION: N/A. PLEASE NOTE THE DEVICES WERE PROVIDED AND BROUGHT TO THE HOSPITAL BY THE SURGEON WHO DID THE SURGERY, AND THE SURGEON HAS CONFIRMED THAT THE DEVICE WAS USED ON ANOTHER PATIENT BEFORE. THE DEVICES HAVE ALREADY BEEN REMOVED FROM THE PATIENT AND ARE CURRENTLY AVAILABLE WITH THE PATIENT. NOTE BY THE LOCAL DISTRIBUTOR: ITEMS SOLD TO THE SURGEON ON 2021 AND IMPLANTED FOR THE FIRST TIME ON 2021, THE SURGEON REUSE THE IMPLANTS ON HIS OWN RESPONSIBILITY WITHOUT GETTING BACK TO US ON OTHER PATIENT AND THE COMPLAINT RAISED BY ANOTHER PATIENT IMPLANTED THE ITEMS ON 2022. THE PATIENT PLAN FOR LENGTHENING 6 CM, AFTER LENGTHENING OF 3.6 CM SUFFER FROM LIMPNESS AND INFECTION. ORTHOFIX SRL REF: (B)(4) DISTRIBUTOR REF: (B)(4) PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2024-00028 FOLLOW UP 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 669569 | ADV LRS KIT 300MM | ADV LRS KIT 300MM | JDW | ORTHOFIX SRL | B1543107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |