1.5/0.6 2MM LEFORT PLATE
Report
- Report Number
- 0001032347-2023-00237
- Event Type
- Injury
- Date Received
- June 21, 2023
- Date of Event
- March 28, 2023
- Report Date
- August 30, 2024
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- UDI-DI
- 00841036011680
- PMA / PMN Number
- K121589
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS: ITEM # 01-6482, LOT # 161370; 1.5/0.6 2MM LEFORT PLATE; QTY 2; ITEM # 95-1805, LOT # 273127F; 1.8X5MM HT X-DR SCREW; ITEM # 95-1505, LOT # 273727F; 1.5X5MM HT X-DR SCREW; QTY 21. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2023-00237; 0001032347-2023-00238; 0001032347-2023-00239; 0001032347-2023-00240; 0001032347-2023-00241; 0001032347-2023-00242; 0001032347-2023-00243; 0001032347-2023-00244; 0001032347-2023-00245; 0001032347-2023-00246; 0001032347-2023-00247; 0001032347-2023-00248; 0001032347-2023-00249; 0001032347-2023-00250; 0001032347-2023-00251; 0001032347-2023-00252; 0001032347-2023-00253; 0001032347-2023-00254; 0001032347-2023-00255; 0001032347-2023-00256; 0001032347-2023-00257; 0001032347-2023-00258; 0001032347-2023-00259; 0001032347-2023-00260.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF CUSTOMER-PROVIDED PHOTOS SHOWS FRACTURES OF TWO PLATES. NO DEFECTS COULD BE CONFIRMED ON THE PHOTOS OF THE 22 REPORTED SCREWS. AS THE REASON FOR REVISION IS UNKNOWN, NO CONCLUSIONS CAN BE MADE BY THESE PHOTOS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PLATES AND SCREWS. BOTH PLATES AND THE SCREWS SHOW SIGNS OF ATTEMPTED USE INCLUDING MARKING AND SCRATCHING ON THE PRODUCT SURFACES. BOTH PLATES HAVE FRACTURED. THE RETURNED DEVICES WERE EVALUATED WITH OPTICAL MICROSCOPY AND SCANNING ELECTRON MICROSCOPY. SEM IMAGES OF THE FRACTURE SURFACES OF THE TWO PLATES SHOW FATIGUE STRIATIONS, SUGGESTING THE FATIGUE FAILURE MODE. SEMI QUANTITATIVE EDS ELEMENTAL ANALYSIS FOUND THE MATERIAL TO BE CONSISTENT WITH TITANIUM WITH MINOR CARBON CONTAMINATION. FOR THE 22 RETURNED SCREWS ALL SCREWS SHOW SIGNS OF LIGHT USE WITH MINOR MARKING ON THE SCREW SURFACES. ALL SCREWS HOWEVER ARE INTACT WITH NO SIGNS OF DAMAGE. THE SCREWS ARE FULLY FUNCTIONAL WITH NO ISSUES FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON PRODUCT RETURN. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D9, G3, G6, H2, H3, H6, AND H11.
IT IS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE, AND SUBSEQUENTLY WAS REVISED FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND 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 |
|---|---|---|---|---|---|---|---|
| 1986897 | 1.5/0.6 2MM LEFORT PLATE | PLATE, BONE | JEY | BIOMET MICROFIXATION | N/A | 161370 | 00841036011680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R | SEE H10 |