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 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, the drill was taken more bone than planned during femur medial condyle burring.Check points were used and both femur and tibia were correct.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.

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, and the cori log files and/or case files were not provided.Therefore, visual and functional inspections and log/case file assessments could not be performed.A short video clip of the femur bone removal screen was provided and reviewed with clinical account representatives.Half of the femur cut was red, confirming the reported complaint.The over-resection of the femur bone model is likely due to bone tracker movement.Evidence of bone tracker movement could be an entire area of the bone model showing red.Bone tracker movement shifts the entire virtual bone model from its original position defined in the checkpoint definition screen.The drill is then mislocated in relation to the virtual bone model.This is evident when, in real time bone removal, the model is updating to show an accumulated area of red bone consistent with the bur and it¿s contact with the virtual bone.Therefore, when screenshots show large, red areas of the bone surface, it is suspected that the bone trackers moved.Although there are no checkpoint verification errors, if the checkpoints were taken on the bone clamp or the bone tracker, then tracker movement would have gone undetected because the checkpoint is still the same distance from the flat markers on the bone tracker.Refer to the real intelligence cori for knee arthroplasty for inserting checkpoint pins and defining checkpoints.Checkpoint pins are inserted in both the femur and the tibia, in positions where they will not be disturbed during bone removal.These points are collected as data points using the point probe within cori application software.Throughout the surgical procedure, the ¿checkpoints¿ are referenced to determine if either tracker has moved.The clinical/medical evaluation concluded: ¿based on the information provided, the clinical root cause of the reported instances of the ¿drill taking more bone than planned¿ could not be definitively concluded; however, user technique could not be ruled as a contributing factor and this may be supported by the product evaluation which reported the over-resection of the bone model ¿is likely due to bone tracker movement¿.The assessed patient impact was the over-burring of the operative bone, subsequent change in surgical technique, and resulting surgical delay of 0-30minutes.Further patient impact could not be assessed as the current patient status remains unknown.No further medical assessment can be rendered at this time.¿ this situation is captured in the risk assessment released at the time of the complaint.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: 12844110
• MDR Text Key: 281014623
• Report Number: 3010266064-2021-00783
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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?: No
• 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
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/07/2022
• 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: A
• Patient Sequence Number: 1