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

Model Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Unintended Application Program Shut Down (4032)

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

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a cori assisted surgery, when they were changing the plan after burring the distal femur, they moved to bur all of the tibia.They began to bur the tibia and an "internal error" popped up and said "application quit unexpectedly." they were able to quit out of the case, go back in, recalibrate the drill.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that during a cori assisted surgery, when they were changing the plan after burring the distal femur (because the surgeon felt the joint was too tight in extension, therefore they resected 1-2 more mm from the distal femur), they moved to bur all of the tibia.They began to bur the tibia and an "internal error" popped up and said "application quit unexpectedly." they were able to quit out of the case, go back in, recalibrate the drill.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn:(b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation.The application log file (navio.Log) confirmed the intraop exited upon transitioning to ¿tibia bone removal,¿ confirming that the intraop likely crashed, and displayed the internal error message to the user.An internal error message is a result of an intraop crash.However, the log files (naviosystem.Log, xsession.Log, and/or coredump) needed for further investigation of the intraop crash were not provided for review.The most likely cause of the internal error is an occurrence of a known software defect that is under investigation.Refer to appendix d: recovery procedure guidelines in the real intelligence¿ cori¿ for knee arthroplasty user¿s manual.In the event of a system failure, cori has a built-in auto-recovery mechanism.If the failure occurs during the procedure, cori returns to the startup screens outside of the application.Cori prompts with the choice whether to resume the operation.Selecting yes returns to a specified checkpoint within the procedure, depending on when the failure occurred.If the failure occurs outside of the application, cori returns to the beginning of the startup sequence.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 risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14141907
• MDR Text Key: 289518090
• Report Number: 3010266064-2022-00304
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 06/13/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention