VELYS ARRAY SET KNEE
Report
- Report Number
- 1818910-2024-17349
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- August 9, 2024
- Report Date
- August 13, 2024
- Manufacturer
- DEPUY IRELAND - 3015516266
- Product Code
- OLO
- UDI-DI
- 10603295520146
- PMA / PMN Number
- K202769
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, "ARRAYS WON'T PASS THE POINTER CHECKS". ADDITIONAL INFORMATION WAS PROVIDED INDICATING IT WAS THE SAW ARRAY WHICH WOULD NOT PASS. WHEN THEY WOULD COMPLETE THE SAW BLADE CALIBRATION IT WOULD FAIL. ALL FIVE ARRAY COMPONENTS OF THE VELYS ARRAY SET KNEE (P/N 451570011, LOT UNKNOWN) ASSOCIATED WITH THIS REPORT WAS RETURNED TO J&J MEDTECH ORTHOPEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED ARRAYS FOUND NO SIGNIFICANT DAMAGE OR VISUAL DEFECTS WITH THE DEVICES. SLIGHT SCRATCHES/ABRASIONS WERE NOTED ON THE ARRAY LENSES, HOWEVER THIS IS LIKELY DO TO TRANSIT AND THE SCRATCHES ARE NOT SIGNIFICANT ENOUGH TO CONTRIBUTE TO THE REPORTED EVENT. FUNCTIONAL EVALUATION PER IFU-0902-60-022 SECTION: SYSTEM SETUP - POINTER CHECK, USING PRODUCTION EQUIVALENT DEVICES AND ROBOT, COULD NOT REPLICATE THE REPORTED ISSUE. THE SAW ARRAY PASS THE POINTER CHECK WITH THE RETURNED POINTER AND PASSED SAW BLADE CALIBRATION WITH A PRODUCT EQUIVALENT SAW HANDPIECE (RBY-V-SH-062) AND SAW BLADE (PN: 451570000 LOT#: P13281). FURTHERMORE, ALL OF THE RETURNED ARRAYS WERE RECOGNIZED BY THE CAMERA. REFER TO APPENDIX 1: SYSTEM TROUBLESHOOTING OF IFU-0902-60-022, FOR INSTRUCTIONS OF HOW TO TROUBLESHOOT "POINTER CHECK FAILED" ERROR. THE POINT CHECK FAILED ERROR IS INTENDED TO LET THE USER KNOW THAT THE POINTER WAS NOT POSITIONED CORRECTLY OR THERE COULD BE DEBRIS INTERFERENCE WHICH MUST BE CLEARED FROM THE SAW BLADED FOR GOOD CONTACT. THERE WERE NO ERRORS FOUND DURING EVALUATION, THEREFORE, A DEFINITIVE CAUSE FOR THE ERROR COULD NOT BE ESTABLISHED. BASED ON THE INVESTIGATION FINDINGS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. D9, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.
PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT#: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT THE ARRAYS WON'T PASS THE POINTER CHECKS. ISSUE WAS OBSERVED INTRA-OP ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
ADDITIONAL INFORMATION WAS RECEIVED: QUESTION: WHICH ARRAYS WOULD NOT PASS THE POINTER CHECKS? SAW ARRAY, TIBIA ARRAY, FEMUR ARRAY? RESPONSE: SAW ARRAY. QUESTION: WHAT STEP IN THE SYSTEM SETUP PROCEDURE WERE THEY WHEN THE ARRAYS WOULD NOT PASS THE POINTER CHECKS? RESPONSE: WHEN WE COMPLETE THE SAW BLADE CALIBRATION IT WILL FAIL. QUESTION: WHERE WAS THE CAMERA POSITIONED IN THE ROOM AT THAT TIME? RESPONSE: THE CAMERA WAS IN THE CORNER OF THE ROOM. QUESTION: DID THE SETUP LOOK SOMETHING LIKE WHAT WAS SHOWN IN THE ILLUSTRATION FROM THE IFU? RESPONSE: YES, BUT WE WERE CALIBRATING THE SAW SO IT WAS NOT ATTACHED TO THE ROBOT YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1177441 | VELYS ARRAY SET KNEE | ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY | OLO | DEPUY IRELAND - 3015516266 | 10603295520146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |