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

Model Number ROB10024

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

It was reported that during cori tka procedure when advancing to the tibia cut screen, a bone model generation error occurred.Went back to collect more tibia points but could not clear error.Cleared tibia bone mesh and recollected.Proceeded to tibia cut screen and completed case.Delay reported less than 30 minutes.No patient harm or additional complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.Screenshots of the case were provided and reviewed.The screenshots confirmed the warning message upon entering the tibia bone removal stage: ¿bone model generation error¿.The user returned to the free collection screen and attempted to re-collect points on the tibia but received the same ¿bone model generation error¿ warning.The user was then able to recollect the tibia bone and proceed to the tibia cut screen without the error.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.The most likely cause of the tibia bone model generation error is a known software bug associated with the bone mesh generation.This defect requires the user to recollect surface points after receiving an error.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: 10824848
• MDR Text Key: 215932909
• Report Number: 3010266064-2020-01989
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB20000