ROSA ONE BRAIN
Report
- Report Number
- 3009185973-2024-00013
- Event Type
- Injury
- Date Received
- September 30, 2024
- Date of Event
- August 14, 2024
- Report Date
- July 23, 2025
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244032492
- PMA / PMN Number
- K214065
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). H3: THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). UPDATED: A3, B4, B5, D2, D9, G3, H1, H2, H4, H6, H11. A REVIEW OF THE LOG FILES CONFIRMED THE REPORTED EVENT FOR CALIBRATION FAILURE BUT THERE WERE NO ERRORS RELATING TO DRIFTING OBSERVED. THE SURGERY WAS NOT COMPLETED AND WAS ABORTED. THE BONE FIDUCIALS WERE PLACED BUT NO INCISIONS FOR THE IMPLANTS OCCURRED. A FIELD SERVICE ENGINEER WAS ONSITE TO EVALUATE THE SITUATION AFTER THE ABORTED CASE. THEY RESET THE SOFTWARE AND RECALIBRATED THE TOOLS AND FORCE SENSOR AND REPLACED THE CALIBRATION FILES. THE ROBOT WAS WORKING AS INTENDED AT THAT TIME. THE LOANER UNIT WAS INSTALLED TWO DAYS LATER, AND THE CASE WAS COMPLETED WITHOUT ADDITIONAL ISSUE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE (UPDATE/CORRECTED). CORRECTED: G4. UPDATED: G3; H2.
IT WAS REPORTED THAT APPROXIMATELY A MONTH AGO A PATIENT WAS PUT UNDER ANESTHESIA AND HAD BONE FIDUCIALS PUT IN WHEN THE CASE HAD TO BE ABORTED DUE TO A DRIFTING ARM AND BEING UNABLE TO CALIBRATE THE TOOLS. THE SURGERY WAS COMPLETED TWO DAYS LATER.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602706 | ROSA ONE BRAIN | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTECH SAS | N/A | N/A | 03760244032492 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |