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 08/20/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted tka surgery, while the surgeon was milling the distal femur, he brought the burr just over the medial edge of the femur and the burr plunged and created a significant defect off the medial side by cutting more bone than anticipated.There was no colored bone to remove, the surface was white.The procedure was completed, without delay, using the same device.Patient was not harmed beyond the issue reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The product was not returned however 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 and confirmed red bone (overcut) along the outer edge of the medial condyle.Contributing factors for the overcut could be due to quick movement of the drill while the bur was exposed over the bone edge.¿spare bone¿ is the white bone of the virtual model that is not to be resected.Spare bone includes the target surface that the drill burs to.The given distance between the drill guard and the spare bone is used by the ¿projective aggressive¿ algorithm to determine the allowed bur exposure.The bur is going to extend out to the depicted version of the bone model.Regardless if there is bone to be removed or not, the bur will extend to reach spare bone if it is within the bur¿s maximum exposure range.Upon reaching that spare bone, it would not resect.However, over-resection is possible when the bur is exposed and the drill moves quicker than the expected retraction time over spare bone that is now closer to the guard.This is most noticeable when the guard is at an angle with, and not perpendicular to, the bone.The guard is more likely to create these angles when moved back and forth near the edges of the bone.According to the cori user's manual, utilize exposure control mode with the bur working perpendicular to the cutting surface is recommended for easily accessible areas that are unrestricted by boney anatomy.Trace around the outer edge of the implant cut plan.Make left-right or up-down passes to remove the remaining middle bone.The user should avoid quick passes of the tool over the surface.To remove bulk bone, a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur remains protruded only until it has reached the target surface, and the bur exposure actively adjusts so that cutting beyond the target surface is minimized.When removing bone, the yellow drill symbol will display when the drill movement exceeds the recommended velocity, which may lead to overcutting.The clinical/medical evaluation concluded: ¿based on information provided, the clinical root cause could not be definitively concluded.Reportedly, there was no patient injury and there was no impact on the outcome; however, the assessed patient impact is the reported ¿significant medial-side defect¿ (laceration/¿more bone taken than anticipated¿) also noted in the provided screenshots.The user manual [07/2020 500230 revd] does warn that the software only tracks operative bone and to avoid tissues not intended to be cut.No further medical assessment could 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.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used in treatment was not returned to the designated complaint unit for evaluation, therefore, visual and functional inspections could not be performed.The product was not returned however 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 and confirmed red bone (overcut) along the outer edge of the medial condyle.The most likely cause of this event is associated with the a software defect.¿spare bone¿ is the white bone of the virtual model that is not to be resected.Spare bone includes the target surface that the drill burs to.The given distance between the drill guard and the spare bone is used by the ¿projective aggressive¿ algorithm to determine the allowed bur exposure.The bur is going to extend out to the depicted version of the bone model.Regardless if there is bone to be removed or not, the bur will extend to reach spare bone if it is within the bur¿s maximum exposure range.Upon reaching that spare bone, it would not resect.However, over-resection is possible when the bur is exposed and the drill moves quicker than the expected retraction time over spare bone that is now closer to the guard.This is most noticeable when the guard is at an angle with, and not perpendicular to, the bone.The guard is more likely to create these angles when moved back and forth near the edges of the bone.According to the cori user's manual, utilize exposure control mode with the bur working perpendicular to the cutting surface is recommended for easily accessible areas that are unrestricted by boney anatomy.Trace around the outer edge of the implant cut plan.Make left-right or up-down passes to remove the remaining middle bone.The user should avoid quick passes of the tool over the surface.To remove bulk bone, a slow, methodic ¿plunge and drag motion¿ through to the cortical layer, will remove bone with the greatest efficiency.The bur remains protruded only until it has reached the target surface, and the bur exposure actively adjusts so that cutting beyond the target surface is minimized.When removing bone, the yellow drill symbol will display when the drill movement exceeds the recommended velocity, which may lead to overcutting.The clinical/medical evaluation concluded: ¿based on information provided, the clinical root cause could not be definitively concluded.Reportedly, there was no patient injury and there was no impact on the outcome; however, the assessed patient impact is the reported ¿significant medial-side defect¿ (laceration/¿more bone taken than anticipated¿) also noted in the provided screenshots.The user manual [07/2020 500230 revd] does warn that the software only tracks operative bone and to avoid tissues not intended to be cut.No further medical assessment could 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 historical escalation event review was completed.The review determined that prior escalation actions are applicable to the part number or serial number and scope of this complaint, and no further escalation action is required.As part of corrective action, this software defect has been resolved on cori software version 1.7.1 and above.The failure mode will continue to be 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: 12454449
• MDR Text Key: 270857154
• Report Number: 3010266064-2021-00635
• 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,Followup
• Report Date: 06/07/2024

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 Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 02/02/2022; 06/05/2024
• Supplement Dates FDA Received: 02/03/2022; 06/07/2024
• 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
• Patient Outcome(s): Required Intervention