MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that during cori legion cr tka procedure, they passed drill diagnostics prior to case creation and there were no errors leading up to distal femur cut.However, when entered distal femur cut screen, bur was not exposing past the guard ((b)(4)).About 7-10 seconds into this screen, with no bone being cut due to lack of bur exposure, a bad console error pops up on screen ((b)(4)).The peak plasma blade was in use during this case (at 8 and 6) though not actively cauterizing at the time of the distal cut.Began troubleshooting: initially exited case and immediately re-entered, but the 24 inch touchscreen was flickering ((b)(4)), so quit and exited the case and completely shut down the system.Upon restart, re-entered case without issue.Completed case through initial post-op gap assessment with cori, but then needed to recut tibia and could not replace cut block with tibia array in place (covered on (b)(4)), so removed array and completed re-cut and re-trialing manually.Delay reported of fewer than 30 minutes.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was returned to the designated complaint unit for evaluation.No visual non-conformances were identified.A functional evaluation as well as the case file review confirmed the occurrence of the "system console is bad" error message.A functional evaluation was performed where a case was run using the console, and a "system console is bad" error message was presented at the test spin screen.Although this error was functionally confirmed, the log file review of the case identified an overheat error resulting in the "system console is bad" error message.This is a tcu hardware/electrical issue (within the console), and the detection of this error is an expected behavior of the system.The software is designed to detect hardware problems.Contributing factors to the overheat error could be: too much pressure applied to the drill when burring, the bur being unlocked for an extended period of time the bur was loaded incorrectly debris is stuck in the exposure, and the system may be trying to move the exposure and it's not moving.Any of the above causes of the overheat error results in the tool needing to cool down to recover from the error.Sometimes these errors are glitches, however, if the error continues to occur after multiple restarts of the cori system, a tcu hardware component may be faulty and needs replaced.The ¿system console is bad¿ error message is a system fault error message that requires the user to restart or shut down the cori system.Refer to appendix c in of the real intelligence cori for knee arthroplasty user manual.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual.A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.This situation is captured in the optimus risk assessment released at the time of the complaint.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports, this issue will continue to be monitored.Prior escalation criteria was reviewed, and there are no prior escalation actions applicable to the scope of the reported complaint.Although no further action is necessary at this time, the issue will be continuously monitored through complaint investigation and post market surveillance.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 2905 northwest blvd ste 40; plymouth, MN 55441 ; 5123913905
• MDR Report Key: 11580332
• MDR Text Key: 242801403
• Report Number: 3010266064-2021-00234
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other