CEMENT REMOVAL HANDSET
Report
- Report Number
- 9680825-2019-00011
- Event Type
- Injury
- Date Received
- February 26, 2019
- Date of Event
- January 30, 2019
- Report Date
- March 25, 2019
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDX
- PMA / PMN Number
- K093805
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
ON JULY 2017 ORTHOFIX SRL ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON 18ST FEBRUARY 2019 (GENERATOR AND ONE HANDSET S/N (B)(6)) AND ON 1ST MARCH 2019 (ONE HANDSET S/N (B)(6)), WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. ALL DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK EVIDENCED AS FOLLOWS: 1. THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(6), DID NOT SHOW ANY ANOMALIES. 2. IN THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 SERIAL NUMBER (B)(6), THE HORN IS DAMAGED AS THE PROBE'S THREADED HEAD IS BROKEN INSIDE IT 3. THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 SERIAL NUMBER (B)(6) DID NOT SHOW ANY ANOMALIES. THE FUNCTIONAL CHECK EVIDENCED AS FOLLOWS: 1. THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(6) IS FUNCTIONING PROPERLY. ELECTRICAL SAFETY TESTS WERE PERFORMED, I.E. PAT TEST AND LEAKAGE TEST. ALL CHECKS PASSED. 2. THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H4014, IS NOT FUNCTIONING PROPERLY. THE PROBE IS BROKEN INSIDE THE HORN. ONLY THE THREAD OF THE PROBE WAS RETURNED STUCK INSIDE THE HORN. AS THE BROKEN PORTION OF THE PROBE WAS DISCARDED AT HOSPITAL, IT WAS NOT POSSIBLE TO DETERMINE CODE REFERENCE AND LOT NUMBER OF THE PROBE. 3. THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H4015, IS NOT FUNCTIONING PROPERLY. THE CERAMICS INSIDE THE DEVICE ARE BROKEN. THE GENERATOR SHOWS THE ALERT MESSAGE: "POOR FEEDBACK". MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION, WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS: ON (B)(6) 2019 WE DO NOT KNOW THE NATURE OF THE MALFUNCTION OF THE OSCAR EQUIPMENT. PRESUMABLY THEY HAD TO COMPLETE THE CEMENT REMOVAL WITH MANUAL INSTRUMENTS WHICH WOULD HAVE TAKEN AND EXTRA 60 TO 90 MINUTES. IT SO HAPPENS THAT THE SECONDARY METHOD OF PERFORMING CEMENT REMOVAL, WITH HAND INSTRUMENTS, TAKES AN EXTRA 60 TO 90 MINUTES. WE ARE NOW ASSUMING THAT THE USE OF THE OSCAR IS THE GOLD STANDARD AND THAT THE OLD METHOD IS THE FALL-BACK. THE BASIC STORY IS THAT THE OSCAR SYSTEM DID NOT WORK AND THE OPERATION WAS SIGNIFICANTLY LONGER AS A RESULT. WE SHALL HAVE TO WAIT FOR THE TECHNICAL ANALYSIS. ON (B)(6) 2019 WITH THE OUTCOME OF THE TECHNICAL ANALYSIS: THIS TECHNICAL ANALYSIS SHOWS THAT THE OSCAR GENERATOR WAS FUNCTIONING NORMALLY, AND PASSED ALL THE SAFETY TESTS. HOWEVER BOTH HANDSETS HAD FAILED FOR DIFFERENT REASONS: ONE HANDSET HAD A BROKEN PIECE OF THE PROBE STILL INSIDE THE HORN, WHICH RENDERED THE DEVICE NON FUNCTIONAL. THIS PROBABLY HAPPENED BECAUSE OF EXCESSIVE TORQUE WHEN TIGHTENING THE JOINT WHILE ATTACHING THE PROBE. THE OTHER HANDSET HAD BROKEN CERAMICS INTERNALLY WHICH MADE THE DEVICE NON-FUNCTIONAL. THIS IS ATTRIBUTED TO WEAR AND TEAR: THE NORMAL DEGRADATION THAT OCCURS WITH MULTIPLE PROCESSING AND REUSE. FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1. THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(6) IS FUNCTIONING PROPERLY. ALL THE TESTS PERFORMED PASSED. 2. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H4014 IS MOST LIKELY TO BE ATTRIBUTABLE TO EXCESSIVE TORQUE APPLIED TO CLOSE THE PROBE IN THE HORN. OTHER POSSIBLE CAUSES COULD BE RELATED TO UNFORESEEN CONTACT WITH ANOTHER METAL OR INCORRECT APPLIED FORCE THAT LED TO ABNORMAL ULTRASOUND RESONANCE OF THE PROBE. 3. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H4015, IS MOST LIKELY ATTRIBUTABLE TO WEAR AND TEAR OF THE CERAMICS INSIDE THE DEVICE. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: THIS TECHNICAL ANALYSIS SHOWS THAT THE OSCAR GENERATOR WAS FUNCTIONING NORMALLY, AND PASSED ALL THE SAFETY TESTS. HOWEVER BOTH HANDSETS HAD FAILED FOR DIFFERENT REASONS: ONE HANDSET HAD A BROKEN PIECE OF THE PROBE STILL INSIDE THE HORN, WHICH RENDERED THE DEVICE NON FUNCTIONAL. THIS PROBABLY HAPPENED BECAUSE OF EXCESSIVE TORQUE WHEN TIGHTENING THE JOINT WHILE ATTACHING THE PROBE. THE OTHER HANDSET HAD BROKEN CERAMICS INTERNALLY WHICH MADE THE DEVICE NON-FUNCTIONAL. THIS IS ATTRIBUTED TO WEAR AND TEAR: THE NORMAL DEGRADATION THAT OCCURS WITH MULTIPLE PROCESSING AND REUSE. BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO THE CONDITIONS OF USE OF THE DEVICES. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00010 FOLLOW UP 1 AND MFR REPORT NUMBER 9680825-2019-00012 FOLLOW UP 1.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6) HOSPITAL. - SURGEON NAME: MR (B)(6) . - DATE OF INITIAL SURGERY: (B)(6) 2019. - BODY PART TO WHICH DEVICE WAS APPLIED: HIP REVISION. - SURGERY DESCRIPTION: REVISION EPR. - PATIENT INFORMATION: FEMALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "STAFF COULD NOT BE CERTAIN IF THE HANDPIECE OR CONSOLE WAS SHORTING OUT." THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT LED TO A CLINICALLY RELEVANT INCREASE 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 REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. ON FEBRUARY 21, 2019, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "I THINK IT TOOK US EXTRA HOUR TO HOUR AND A HALF TO FINISH THE CASE". MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).
ON JULY 2017 ORTHOFIX (B)(4) ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX (B)(4) IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: THE GENERATOR AND ONE HANDSET WERE RECEIVED BY ORTHOFIX (B)(4) ON 18 FEBRUARY 2019. THE SECOND HANDSET IS STILL NOT RETURNED. ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS ALL DEVICES ARE AVAILABLE. MEDICAL EVALUATION: THE INFORMATION 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 (B)(4) WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00010 AND MFR REPORT NUMBER 9680825-2019-00012.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: MR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: HIP REVISION. SURGERY DESCRIPTION: REVISION EPR. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "STAFF COULD NOT BE CERTAIN IF THE HANDPIECE OR CONSOLE WAS SHORTING OUT." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE 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 REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. ON (B)(6) 2019, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "I THINK IT TOOK US EXTRA HOUR TO HOUR AND A HALF TO FINISH THE CASE". (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162973 | CEMENT REMOVAL HANDSET | CEMENT REMOVAL HANDSET | JDX | ORTHOFIX SRL | OH300/2 | 3H4014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |