VELYS ARRAY CLAMP
Report
- Report Number
- 1818910-2022-00879
- Event Type
- Malfunction
- Date Received
- January 18, 2022
- Date of Event
- January 6, 2022
- Report Date
- January 18, 2022
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- HWM
- UDI-DI
- 10603295519379
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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, 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. 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, H3, 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. D4, H4: THE DEVICE SERIAL/LOT NUMBER AND MANUFACTURE DATE WAS UNKNOWN IN THE INITIAL REPORT AND HAVE BEEN UPDATED ACCORDINGLY. D11, CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ARRAY CLAMP DEVICE AND ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE, (B)(6) 2022. UDI:(B)(4). D2B: THE DEVICE PRO-CODE WAS REPORTED AS HWM IN THE INITIAL REPORT AND HAS BEEN UPDATED ACCORDINGLY. B5: THE EVENT DESCRIPTION HAS BEEN UPDATED TO INCLUDE ADDITIONAL EVENT INFORMATION AND CONCOMITANT DEVICES.
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, 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. 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. INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE DID NOT CONFIRM THE COMPLAINT. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. THE COMPLAINT SAMPLE WAS FORWARDED TO PRODUCT DEVELOPMENT FOR FURTHER EVALUATION (SEE REPORT ATTACHED FOR FURTHER DETAILS). VISUAL INSPECTION UNDER MAGNIFICATION AND TEST FIT WITH MATING PARTS WERE PERFORMED. VIDEO WAS REVIEWED, USER MISUSE WAS IDENTIFIED. ARRAY SHOULD NOT BE USED AS A HANDLE, AND SHOULD NOT BE REMOVED WITHOUT ENGAGING THE BUTTON. HOWEVER, FIT WAS CHECKED WITH ARRAYS AND CONFIRMED TO BE GOOD. NO LOOSE FIT WAS PERCEPTIBLE. REVIEW OF DEVICE MANUFACTURING RECORDS INDICATES THAT THERE WERE NO ANOMALIES WITH REGARD TO MANUFACTURING OR INSPECTION CONTAINED IN THE DEVICE HISTORY RECORDS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
THE ARRAY CLAMPS ARE NOT HOLDING THE ARRAYS SECURELY IF THE ARRAY IS PHYSICALLY MOVED AND BUTTON IS NOT BEING PUSHED. RIGHT SASI IS NOT CLAMPING SECURELY. BOTH ISSUES WERE DISCOVERED BEFORE SURGERY.
THE ARRAY CLAMPS ARE NOT HOLDING THE ARRAYS SECURELY IF THE ARRAY IS PHYSICALLY MOVED AND BUTTON IS NOT BEING PUSHED. RIGHT SASI IS NOT CLAMPING SECURELY. BOTH ISSUES WERE DISCOVERED BEFORE SURGERY.
THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT WHILE SETTING UP FOR SURGERY, IT WAS OBSERVED THAT THE ARRAY CLAMPS (X2) WERE NOT HOLDING THE ARRAYS SECURELY WHEN THE ARRAY IS PHYSICALLY MOVED AND THE BUTTON IS NOT PUSHED. IT WAS ALSO REPORTED THAT THE DURING THE SAME PRE-SURGERY SET UP IT WAS DISCOVERED THAT THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE WAS NOT CLAMPING SECURELY. IT WAS REPORTED THAT THE ISSUES WERE DISCOVERED PRIOR TO THE BEGINNING OF THE SURGERY AND THEREFORE THE PROCEDURE WAS CANCELLED AND RE-SCHEDULED FOR ANOTHER DAY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215933 | VELYS ARRAY CLAMP | ORTHOPEDIC STEREOTAXIC INSTRUMENT | HWM | DEPUY IRELAND - 9616671 | 4515-70-107 | J43053 | 10603295519379 |
| 746409 | VELYS ARRAY CLAMP | ORTHOPEDIC STEREOTAXIC INSTRUMENT | HWM | DEPUY IRELAND - 9616671 | 4515-70-107 | J43053 | 10603295519379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |