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 05/12/2021

Event Type  malfunction  

Event Description

It was reported that during a cori assisted tka surgery while cutting the anterior femur, the real intelligence robotic drill had a disconnect error message (case (b)(4)), it was proceed to quit out of the case and was then prompted an "internal error" message (case-(b)(4)).They dismissed the message and disconnected the drill.The drill was then reconnected and were able to resume the surgery.Later, while entering the tibia bone removal screen, a bone model generation error message was prompted (case(b)(4)), then they added a couple more collection points to the tibia and were able to proceed to tibia bone removal.The procedure was completed with a minimal delay (fewer than 30 minutes) using the same devices.No patient injuries and no other complications were reported.

Manufacturer Narrative

The real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, and the log files required to confirm the internal error as well as the tibia bone mesh generation error were not provided.Therefore, visual and functional inspections and log/case file assessments could not be performed.The reported errors could not be confirmed, however, both errors are likely to be occurrences of known software issues that have been corrected and released in cori-v1.4.3 software.In the event of a system failure, refer to the recovery procedure guidelines in the cori user¿s 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.Refer to the real intelligence cori for knee arthroplasty user manual for data point collection, including tibia free collection.If a collection error occurs, a message displays, reporting the specific error to the user, and providing instruction for solution.Most indications require clearing the message from the screen, by pressing ok, and performing the steps again to re-collect.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.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.If the case files associated with this event are returned at a future date, this evaluation will be reopened for investigation.No containment or corrective actions are recommended at this time.

• 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: 11891098
• MDR Text Key: 257599857
• Report Number: 3010266064-2021-00419
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• 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