RIBFIX BLU SYSTEM 8 HOLE STRAIGHT PLATE
Report
- Report Number
- 0001032347-2024-00070
- Event Type
- Injury
- Date Received
- March 1, 2024
- Date of Event
- February 9, 2024
- Report Date
- July 30, 2024
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- PMA / PMN Number
- K142823
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT: (B)(4). G3: FOREIGN SOURCE: GERMANY. D10 ¿ MEDICAL PRODUCTS: ITEM#: 76-2601 LOT#: UNK, RIBFIX BLU SYSTEM 8 HOLE STRAIGHT PLATE. ITEM#: 76-2602 LOT#: UNK, RIBFIX BLU SYSTEM 12 HOLE PREBENT PLATE. ITEM#: UNK, LOT#: UNK, UNKNOWN SCREW QTY (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2024-00071, 0001032347-2024-00072, 0001032347-2024-00073, 0001032347-2024-00074, 0001032347-2024-00075, 0001032347-2024-00076, 0001032347-2024-00077, 0001032347-2024-00078, 0001032347-2024-00079, 0001032347-2024-000780, 0001032347-2024-000781, 0001032347-2024-000782, 0001032347-2024-000783, 0001032347-2024-000784, AND 0001032347-2024-000785. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT WAS REPORTED THAT THE SURGEON REATTACHED ONE OF THE PLATES SEVERAL TIMES AND THE SURGEON WAS INFORMED ABOUT THE POSSIBLE LOOSENING OF IMPLANTS RESULTING FROM THE OFF-LABEL USE DURING REPEATED INSERTION ATTEMPTS. THE IFU FOR THESE PLATES STATES: SINGLE USE DEVICE. DO NOT REUSE IMPLANTS. WHILE AN IMPLANT MAY APPEAR UNDAMAGED, PREVIOUS STRESS MAY HAVE CREATED IMPERFECTIONS THAT WOULD REDUCE THE SERVICE LIFE OF THE IMPLANT. DO NOT TREAT PATIENTS WITH IMPLANTS THAT HAVE BEEN EVEN MOMENTARILY PLACED IN A DIFFERENT PATIENT. HOWEVER, IT COULD NOT BE CONFIRMED IF THE ISSUE WAS RESULT OF OTHER FACTORS, SUCH AS POOR PATIENT BONE QUALITY. 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 REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B3, B4, B5, D4, D6, G3, G6, H2, H3, H4, H6, AND H11.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D4, G3, G6, H2, AND H10, H11.
IT WAS REPORTED THAT AFTER INITIAL IMPLANTATION OF PLATES AND SCREWS THE IMPLANTS LOOSENED. THE SURGEON HAD REATTACHED ONE OF THE PLATES SEVERAL TIMES. THE SURGEON WAS INFORMED ABOUT THE POSSIBLE LOOSENING OF IMPLANTS AND THE OFF-LABEL USE DURING THE REPEATED INSERTION. HE REFUSED TO USE A NEW PLATE AND REINSERTED THE 8-HOLE PLATE. THERE WAS A 45-MINUTE DELAY DURING THE PROCEDURE. ACCORDING TO CT IMAGES, BOTH PLATES ARE NOW TORN OUT AND NEED TO BE REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
IT IS FURTHER REPORTED THAT THE PATIENT HAS BEEN REVISED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237079 | RIBFIX BLU SYSTEM 8 HOLE STRAIGHT PLATE | PLATE, FIXATION, BONE | HRS | BIOMET MICROFIXATION | N/A | J7428266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Required Intervention| O | SEE H10. |