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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, the surgeon completed the distal burr down to white bone, as can be seen in the "femur bone removal" screenshot.After using the cutting block and saw to complete the chamfer cuts, the surgeon used the "burr all" screen to "refine" the cuts.A layer of green was seen on the distal surface in the later "femur bone removal" screen.The surgeon removed this very thin layer with the burr.The procedure was completed with the same device without delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

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 software files were downloaded from the device and provided for investigation.Screenshot review confirmed the user had burred to the target surface of the initial femur distal cut.When the user went back to femur bone removal after using the cutting block, there is green bone still showing on the medial condyle in the refine state.A later screenshot in the femur bone removal screens show the green bone on the distal end had been burred to the white target surface.When in refine mode, it is possible that the drill guard had slipped down the long attachment, and was unable to get past the green bone.Later, in ¿bur all¿ mode, it is likely that the user was applying more force when burring, pushing the bur guard back to its correct position on the drill attachment, and therefore refining the green bone.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.As a result of the risk assessment the documented risk file will undergo further investigation by the site quality team.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.Based on the 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: 12643361
• MDR Text Key: 277714327
• Report Number: 3010266064-2021-00718
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1