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 10/22/2020

Event Type  malfunction  

Event Description

It was reported that, during a cori tka procedure, just prior to burring lug holes for tibial cut block, an error message appeared on screen, ¿unable to generate bone model¿.They had the surgeon clear all tibial points and remap.They proceeded with no further complications and with a delay of fewer than 30 minutes.There was no injury to the patient.No other complications were 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.Screenshots of the case were provided and were reviewed to confirm the warning message upon entering the tibia bone removal stage: ¿bone model generation 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.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.As part of corrective actions, this issue has been corrected and released in cori-v1.4.3 software.G1.

• 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: 10813871
• MDR Text Key: 215465123
• Report Number: 3010266064-2020-01982
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB20000, SERIAL: (B)(6)