3.5X60MM CORT LOCK SCR STE
Report
- Report Number
- 0001825034-2022-02436
- Event Type
- Malfunction
- Date Received
- November 2, 2022
- Date of Event
- October 24, 2022
- Report Date
- December 6, 2022
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HRS
- UDI-DI
- 00887868352058
- PMA / PMN Number
- K143697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
(B)(4). REPORT SOURCE: 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H2, H10 D10: ITEM NAME: 3.5X60MM CORT LOCK SCREW CAT #: 856135060 LOT# 942790 QTY OF 9 TOTAL MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02509; 0001825034 - 2022 - 02510; 0001825034 - 2022 - 02511; 0001825034 - 2022 - 02512; 0001825034 - 2022 - 02513; 0001825034 - 2022 - 02514; 0001825034 - 2022 - 02515; 0001825034 - 2022 - 02516.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10 -VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THERE IS A SCRATCH ON THE INNER POUCH ON ALL 9 PRODUCTS. THE SCRATCH DOES NOT GO THROUGH THE POUCH. STERILITY HAS NOT BEEN COMPROMISED. THIS COMPLAINT HAS BEEN CONFIRMED. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. - UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCT WAS NONCONFORMING, AS THE STERILE PACKAGE HAD SCRATCH MARKS ON IT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1305093 | 3.5X60MM CORT LOCK SCR STE | SCREW, PROSTHESIS | HRS | ZIMMER BIOMET, INC. | NI | 942790 | 00887868352058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | SEE H10 |