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

Model Number ROB10024

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

It was reported that during a cori surgeon training, the error message "bone model generation error" appeared when attempted to remove bone on tibia.They were unable to go back and recollect to clear the error message.They had to reboot the system to resume the session.No other complications were reported.

Manufacturer Narrative

H6: the real intelligence cori, pn: rob10024, sn: (b)(6) intended for use in treatment was not returned to the designated complaint unit for evaluation, and the cori log files and/or case files were not provided.Therefore visual and functional inspections and log/case file assessments could not be performed.However, a picture of the ¿bone model generation error¿ warning message was submitted and confirmed the complaint.The software version was not recorded, but dhr review shows that all cori software versions released to the field have been validated.A complaint history did not find similar reports.The most likely cause of the tibia bone model generation error is a known software bug associated with the bone mesh generation.Refer to the real inteligence 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.As part of corrective actions, this issue has been corrected and released in cori-v1.4.3 software.

• 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
• MDR Report Key: 10354586
• MDR Text Key: 201541256
• Report Number: 3010266064-2020-01697
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• 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
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1