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 09/24/2020

Event Type  Injury  

Manufacturer Narrative

The real intelligence cori used for treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.Although the product was not returned the software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives.There were no user-taken screenshots to show the position of the virtual bur flush against the ap plane of the tibia, or the bur perpendicular to the tibial plateau.The user failed checkpoint verification after the first round of tibia bone removal.Log file review found several tibia checkpoint verification attempts with errors ranging from 1.54 to 1.68 mm off (threshold is 1.5 mm).The user then redefined the checkpoints and then began the second round of tibia bone removal.Additional red was observed on the tibial plateau following the checkpoint redefinition.It is likely that the tibia tracker had moved prior to the initial cut, and redefining the tibia checkpoint afterward may have contributed to the additional red.Bone tracker movement shifts the entire virtual bone model from its original position defined in the checkpoint definition screen.The drill and bur are then mislocated in relation to the virtual bone model.Redefinition of checkpoints should only occur if the user is confident that nothing has moved.If a tracker has moved and the checkpoint is redefined, the user needs to start the case over so that the registration steps are re-done to realign the virtual bone model to the physical knee.It should be noted that the patient had significant wear on the medial side of the tibia.The medial side was likely denser because it had been compressed.The plan also showed 13 mm of the lateral side to be re-sected.This is a significant amount of bone to remove, and this depth is typically where the spongey bone is.This bone would be more susceptible to the bur guard pressing down slightly past the target surface and a possible contributing factor for the red on the lateral side of the plateau.Internal complaint reference number: (b)(4).

Event Description

It was reported that during a cori assisted tka procedure, when the bur was flush against the tibia in the ap plane with the drill/handpiece in speed mode, it registers fine for cutting on the bone surface.But when they moved the hand piece to a vertical orientation facing down towards the tibial plateau, the software registers is as over-resecting by a few millimeters.There was a delay of fewer than 30 minutes.No other complications were reported.Upon investigation, it was found that the plan also showed 13 mm of the lateral side to be resected.This is a significant amount of bone to remove, and this depth is typically where the spongey bone is.This bone would be more susceptible to the bur guard pressing down slightly past the target surface and a possible contributing factor for the red on the lateral side of the plateau.

Manufacturer Narrative

H3,.H6:the real intelligence cori, pn: (b)(6), sn: (b)(6) used for treatment was returned for evaluation.The visual inspection and functional investigation did not confirm the reported location discrepancy of the physical drill and the virtual drill.The software files were downloaded from the device and provided for investigation.Caseid: (b)(4) was reviewed.The log files do not indicate any system or software issue related to the reported complaint.The screenshots were reviewed with clinical account representatives.There were no user-taken screenshots to show the position of the virtual bur flush against the ap plane of the tibia, or the bur perpendicular to the tibial plateau.The user failed checkpoint verification after the first round of tibia bone removal.Log file review found several tibia checkpoint verification attempts with errors ranging from 1.54 to 1.68 mm off (threshold is 1.5 mm).The user then redefined the checkpoints and then began the second round of tibia bone removal.Additional red was observed on the tibial plateau following the checkpoint redefinition.It is likely that the tibia tracker had moved prior to the initial cut, and redefining the tibia checkpoint afterward may have contributed to the additional red.Bone tracker movement shifts the entire virtual bone model from its original position defined in the checkpoint definition screen.The drill and bur are then mislocated in relation to the virtual bone model.Redefinition of checkpoints should only occur if the user is confident that nothing has moved.If a tracker has moved and the checkpoint is redefined, the user needs to start the case over so that the registration steps are re-done to realign the virtual bone model to the physical knee.It should be noted that the patient had significant wear on the medial side of the tibia.The medial side was likely denser because it had been compressed.The plan also showed 13 mm of the lateral side to be re-sected.This is a significant amount of bone to remove, and this depth is typically where the spongey bone is.This bone would be more susceptible to the bur guard pressing down slightly past the target surface and a possible contributing factor for the red on the lateral side of the plateau.Refer to the real intelligence cori for knee arthroplasty when addressing checkpoint verification errors.If the checkpoint verification step fails, the option to redefine the checkpoint or start over is presented.Selecting the start over button confirms that the bone trackers have moved and that all anatomic data must be re-collected.The clinical/medical evaluation condluded: ¿per complaint details, while in speed mode, the software registers as ¿over-resecting by a few millimeters¿ when the surgeon moves the hand piece to a vertical orientation facing down towards the tibial plateau and the plan also showed 13 mm of the lateral side to be resected.Reportedly, there was a delay of less than 30 minutes and no other complications were reported.The requested medical documentation has not been provided as of the date of this medical investigation.Per the engineering evaluation, the product functional evaluation could not re-create or confirm the reported issue, but the screenshots/log file review reportedly revealed checkpoint verification errors and suspected tibia tracker movement, as well as the reported plan¿s significant 13mm lateral side resection (likely into spongey bone which would be susceptible to bur guard pressure), as possible contributing factors to the additional red.Without the requested clinical information, the patient impact beyond that which was reported cannot be further assessed.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.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.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: 14102933
• MDR Text Key: 289189134
• Report Number: 3010266064-2022-00281
• 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: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention