ATTUNE RP TIBIAL IMPACTOR
Report
- Report Number
- 1818910-2022-02457
- Event Type
- Malfunction
- Date Received
- February 8, 2022
- Date of Event
- January 26, 2022
- Report Date
- February 8, 2022
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- HWA
- UDI-DI
- 10603295130208
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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). 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. 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). 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). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. EXAMINATION OF THE PHYSICAL PRODUCT CAN CONFIRM THE COMPLAINT. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED
IT WAS REPORTED THAT AN ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR SPLIT INTO TWO PIECES WHILE THE ATTUNE POROCOAT ROTATING PLATFORM TIBIAL BASE (1506-11-007) IMPLANT WAS BEING IMPACTED INTO THE PATIENT'S PROXIMAL TIBIA, DURING HIS PRIMARY KNEE ARTHROPLASTY SURGERY. THE IMPACTION PROCEDURES WAS COMPLETED USING THE ATTUNE FIXED BEARING TIBIAL IMPACTOR FROM THE SAME TRAY OF INSTRUMENTS. THE SURGERY TIME WAS EXTENDED APPROXIMATELY FIFTEEN SECONDS WHILE THE REPLACEMENT IMPACTOR WAS ATTACHED TO THE IMPACTOR HANDLE. THE BROKEN IMPACTOR SPLIT DOWN THE MIDDLE, FROM THE PROXIMAL END TO THE DISTAL END OF THE IMPACTOR. BOTH HALVES OF THE BROKEN IMPACTOR WERE RETRIEVED.
IT WAS REPORTED THAT AN ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR SPLIT INTO TWO PIECES WHILE THE ATTUNE POROCOAT ROTATING PLATFORM TIBIAL BASE (1506-11-007) IMPLANT WAS BEING IMPACTED INTO THE PATIENT'S PROXIMAL TIBIA, DURING HIS PRIMARY KNEE ARTHROPLASTY SURGERY. THE IMPACTION PROCEDURES WAS COMPLETED USING THE ATTUNE FIXED BEARING TIBIAL IMPACTOR FROM THE SAME TRAY OF INSTRUMENTS. THE SURGERY TIME WAS EXTENDED APPROXIMATELY FIFTEEN SECONDS WHILE THE REPLACEMENT IMPACTOR WAS ATTACHED TO THE IMPACTOR HANDLE. THE BROKEN IMPACTOR SPLIT DOWN THE MIDDLE, FROM THE PROXIMAL END TO THE DISTAL END OF THE IMPACTOR. BOTH HALVES OF THE BROKEN IMPACTOR WERE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1301714 | ATTUNE RP TIBIAL IMPACTOR | ATTUNE INSTRUMENTS : IMPACTORS | HWA | DEPUY IRELAND - 9616671 | 2544-01-004 | AU7478286 | 10603295130208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |