ROSA ONE SYSTEM - DE PLUG F
Report
- Report Number
- 3009185973-2023-00018
- Event Type
- Malfunction
- Date Received
- July 25, 2023
- Date of Event
- June 28, 2023
- Report Date
- January 17, 2024
- Manufacturer
- MEDTECH SAS
- Product Code
- HAW
- UDI-DI
- 03760244033758
- PMA / PMN Number
- K200511
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FOLLOW-UP IS SENT TO CORRECT SUMMARY BELOW: INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION DID CONFIRM THE DISCREPANCY BUT NOT THE IMAGE TRANSFER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED TO INVESTIGATE THE IMAGE TRANSFER ISSUE. THE LOG FILES DID NOT REVEAL ANY SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO IMAGES OF THE REGISTRATION PROVIDED TO INVESTIGATE FURTHER FOR POSSIBLE PATIENT REFERENCE MOVEMENT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. BASED ON THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE. POTENTIAL CAUSES FOR THE DISCREPANCY SEEN, BASED ON THE FACTS OBSERVED IN THE LOGS, INCLUDE: MOVEMENT OF PATIENT REFERENCES; INCORRECT 3D RECONSTRUCTION DURING REGISTRATION. 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.
(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION DID CONFIRM THE DISCREPANCY BUT NOT THE IMAGE TRANSFER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED TO INVESTIGATE THE IMAGE TRANSFER ISSUE. THE LOG FILES DID NOT REVEAL ANY SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO IMAGES OF THE REGISTRATION PROVIDED TO INVESTIGATE FURTHER FOR POSSIBLE HEAD MOVEMENT. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. POTENTIAL CAUSES FOR THE DISCREPANCY SEEN, BASED ON THE FACTS OBSERVED IN THE LOGS, INCLUDE: MOVEMENT OF HEAD/HEAD HOLDER. INCORRECT 3D RECONSTRUCTION DURING REGISTRATION 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT WHILE USING THE ROSA ROBOTIC UNIT, WHEN GOING TO TRAJECTORY, IT WAS NOTICED THERE WAS A DISCREPANCY OF ABOUT 1 CM COMPARED TO THE PLANNING. SURGERY WAS ABORTED. THERE WAS A 1-2 HOUR DELAY DUE TO TROUBLESHOOTING THE DATA TRANSFER AND SWITCHING TO CONVENTIONAL. SURGERY WAS COMPLETED WITH CONVENTIONAL INSTRUMENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 599276 | ROSA ONE SYSTEM - DE PLUG F | COMPUTER-ASSISTED SURGICAL DEVICE | HAW | MEDTECH SAS | N/A | 3.1.6.75 | 03760244033758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |