DISPOSABLE MIXING BOWL AND SPATULA
Report
- Report Number
- 0001822565-2024-00396
- Event Type
- Malfunction
- Date Received
- February 5, 2024
- Report Date
- February 28, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- JDZ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
(B)(4). G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND CREASING IN THE SEAL FOR (1) POUCH. A DYE TEST FOUND THE SEAL IS CONFORMING AND STERILITY HAS NOT BEEN BREACHED. NO PRODUCT FAILURE WAS FOUND AS THE PRODUCT IS WITHIN SPECIFICATIONS. THIS COMPLAINT CANNOT BE CONFIRMED AS THE PRODUCT WAS FOUND TO BE CONFORMING. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED BY DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING. IT WAS REPORTED WRINKLES WERE FOUND IN THE SEALING AREA. NO REPORTED PATIENT INVOLVEMENT.
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288905 | DISPOSABLE MIXING BOWL AND SPATULA | HIPS, INSTRUMENTS | JDZ | ZIMMER BIOMET, INC. | N/A | 66384011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |