MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  Injury  

Event Description

It was reported that, during a cori assisted tka surgery, when the surgeon was milling the distal femur, he alerted that the bur took additional bone outside the target zone next to the pcl.He stated that the pcl was not compromised.The case was completed without any delay, using the same device.Patient outcome is unknown.

Manufacturer Narrative

H3, h6: the ri cori, rob10024, sn: (b)(6) (us) used for treatment was not returned for evaluation, however images were provided for review.A relationship between the reported event and the device was confirmed.The intra-op image and image-display appear to support the complaint; however, they do not provide insight into the root cause of the reported event.A functional evaluation could not be performed because the device was not returned and the requested log files were not available.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 has identified prior events.A capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.The root cause of the reported event could not be definitively concluded, however, a contributing factor could be related to tracker movement.Comparing the screenshot of the virtual bone model to the photo of the physical knee, it appears that more bone was physically taken than what was virtually presented on the screen.Log files were not made available to substantiate this possible cause.User technique/variance could not be ruled out as a potential contributing factor to the reported event, either.Per the cori user's manual, checkpoints are referenced to determine if either tracker has moved.If there is concern that a tracker has moved, confirm that the trackers are in the position recorded previously by verifying checkpoints.This failure is an identified failure mode within the risk assessment.Per complaint details, the bur took additional bone outside the target zone/next to the pcl.Reportedly, the case was completed with the same device/cori per typical workflow without delay and the ¿pcl was not compromised¿.The field report indicated no impact on case and no unplanned interventions were required to recover.The provided intra-op image and image-display appear to support the complaint; however, they do not provide insight into the root cause of the reported event.The cori user manual does warn of potential over-cuts due to movement exceeding the recommended velocity, use of cori with disabled control modes, and instructs to avoid tissue(s) that are not intended to be cut.No further clinical information was provided for inclusion in the medical investigation.The clinical root cause of the reported event could not be definitively concluded.Patient impact beyond the reported unplanned bone cuts could not be determined; however, ¿no impact on case and no unplanned interventions were required to recover¿.Any product/engineering evaluation will be performed independent of this medical investigation.No further medical assessment is warranted at this time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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: 12096572
• MDR Text Key: 259378533
• Report Number: 3010266064-2021-00497
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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
• Date Manufacturer Received: 01/11/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other