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

Model Number ROB10024

Device Problem Unintended Application Program Shut Down (4032)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

It was reported that, before a cori tka procedure, they received "system console bad" and "internal error" (system had detected that the application unexpectedly exited) during the unlock of the collet phase of set up.They rebooted the system to proceed without delays.No other complications were reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) intended for use for treatment was returned to the designated complaint unit for evaluation.A visual inspection and functional evaluation were done on the console despite the reported complaint being a software issue that had been confirmed in the case files provided.There were no visual or functional non-conformances related to the reported event identified.The case files were downloaded from the device and provided for investigation.The naviosystem and xsession logs were reviewed and confirmed the ¿system console is bad¿ and ¿internal error¿ messages.The ¿system console is bad¿ error occurred during bur loading.The "system console is bad" error message can occur when the user is in the bur loading workflow and the system times out.The timing out of the system "transitions" the system to a previously identified state, such as the handpiece connection state.However, because the system is transitioning and not in the correct state yet, it is considered to be in a bad state.Therefore, when commands in this workflow are called, such as homing, unlocking the bur, and locking the bur in this bad state, the "system console is bad" error is thrown.The user then exited the application.When going back into the case, an internal error occurred.Further log review found that the internal error was presented to the user when going back into the case.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.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.As part of corrective actions, the software issue related to the system console is bad error has been corrected and released in cori-v1.4.3 software.The internal error occurrence when going back into the case is under investigation by the software engineering team.

• 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: richard confer ; 2828 liberty ave; suite 100; pittsburgh, PA 15222 ; 7634524980
• MDR Report Key: 10784401
• MDR Text Key: 214533887
• Report Number: 3010266064-2020-01953
• 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: K191223
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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: Reuse
• Patient Sequence Number: 1