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

Catalog Number ROB10024

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

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a cori assisted tka surgery while mapping the tibia the entire tibia turned yellow as if it was all filled in.They turned on the green points and proceeded as normal without issue (case- (b)(4)).When the surgeon finished milling the medial distal femoral condyle, moved to the lateral, they received a system time out (case- (b)(4)).They hit continue and proceeded without further issue.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem 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, therefore visual and functional inspections could not be performed.The case files were provided and reviewed.Screenshots confirmed the entire tibia bone, including the shaft and articulating surface appeared to have the solid, yellow mesh in the tibia free collection screen.The most likely cause of the reported issue is a known software issue associated with the mesh generation.A software bug has been identified for this issue and is under further investigated by the software engineering team.Refer to the real intelligence cori for knee arthroplasty user¿s manual.During the free collection stage, points are collected by tracing on the surface of the bone with the point probe.Cori updates continuously to fit the virtual bone surface to the free collection points, displayed as green points, as they are collected.The collected (green) points and the virtual bone surface can be viewed or hidden by toggling their respective buttons on the left of the screen.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: 13153319
• MDR Text Key: 283162224
• Report Number: 3010266064-2022-00008
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556773673
• UDI-Public: 885556773673
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• 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