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 Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

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 burred the anterior portion of the tibia, placed the saw in the cut the rest.After saw cut was complete, he went back to burr all to check the work.It was white but when it came time to prep tibia and trial, the trial wouldn¿t lay flat.It would be flat to bone in front and lifting off posterior or vice versa.They went back and used visualized cut, the system showed that they were at plan.The surgeon decided to go back and take 0.5 mm to try to solve, that didn¿t work.The surgery was completed, after a significant delay, with the same device but also using cut blocks.A saw cut was made to flatten the proximal tibia (4 mm more) and ended up implanting a thicker poly to make up for larger resection (size 18).There was no indication that trackers moved because check points have to be done before making the cuts.

Manufacturer Narrative

H3, h6: the real intelligence cori, rob10024, (b)(6), used for treatment, was not returned for evaluation therefore a visual and functional inspection could not be performed.The reported problem could not be visually or functionally confirmed.A log file/screenshot review was performed.The reported problem was not confirmed.A log file/screenshot review was performed.The reported problem was confirmed, it looks as though the tibia was not milled completely flat which could cause the implant to lay at an angle.It is noted that although the complaint states that the bone was showing white on the cori when it was time to prep the tibia for the trial implant, there was still blue and green showing on the lateral portion of the tibia and green showing on the medial portion of the tibia.Since there is still blue and green showing on the tibia, it is showing that the bone has not been cut flat to plan, and that the implant will sit at an angle.It is possible that the tibia is smaller than what is showing on the screen or that it looked as though the edge of the bone was reached.Since the blue and green colors were not milled from the tibia on the screen, it cannot be confirmed that the cori functioned incorrectly.To avoid this in the future, the ¿refine¿ option can be utilized to ensure that the bone model is showing an accurate depiction of the patient¿s anatomy.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was not completed.The product was not returned, and no evidence was made available to link the complaint to an escalation event.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual (500230 rev d).A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Based on the limited documentation provided, no clinical factors have been identified which would have contributed to the reported event and a user technique/variance cannot be ruled out as a potential contributing factor as the engineering evaluation identified incomplete tibial milling from the logfiles ¿which could cause the implant to lay at an angle¿.The patient impact included the additional (4.5mm total) larger resection to flatten the tibia so the baseplate would sit flush and subsequently required a thicker, 18mm primary tk articulating insert (possibly from a planned 10mm), greater than 30-minute surgical delay, and change in surgical technique to a manual procedure.It is unknown if the native joint line was maintained or if it may increase the risks for future knee joint complications, interventions and/or revision.Further impact could not be determined, although a transient restorative rehabilitation phase would be anticipated.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• 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: 17695010
• MDR Text Key: 322799281
• Report Number: 3010266064-2023-00150
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/05/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Female