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 Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: case-(b)(4).

Event Description

It was reported that, during a cori jii tka procedure, the system showed some slight overcutting beyond the target surface level while they were distal burring the femur using exposure control mode.It¿s unclear if the cause was from the bur or the drill guard rubbing upon the cut bone surface.The procedure was successfully completed without delay using the same device.Additional cuts were not purposely performed.No additional complications were noticed.Final result of component placement was without additional concern.Surgeon was pleased with final result.

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, therefore visual and functional inspections could not be performed.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.The slight over-resection at the surface of the distal cut was confirmed.If the suction tubes aren¿t used, or if the bur guard slipped down, then the user may be more inclined to push toward the bone to overcompensate for the guard slippage.The bur could then push down on the bone just past the target surface and the virtual model would reflect this with a red/pink spot.While in exposure control, the bur remains protruded only until it has reached the target surface, and the bur exposure adjusts actively, so that cutting beyond the target surface is minimized.According to the cori user¿s manual: ¿slide the robotic drill guard onto the robotic drill attachment, until the robotic drill attachment is bottomed out in the guard, which can be verified visually through the t-notch in the guard.¿ the clinical/medical evaluation concluded: ¿per complaint details, the surgeon expressed concern that the drill was over-cutting while in "distal femur" bone removal (b)(4) as some slight overcutting beyond the target surface level occurred while distal burring the femur using exposure control mode (b)(4).The cori user manual [rev d 500230] recommends working perpendicular to the cutting surface while utilizing the exposure control mode which minimizes cutting beyond the target surface.The provided femur bone removal screen shot shows minimal overcut on the virtual femoral surface.Per the field report, there was no impact on the case, no interventions required to recover, and no additional complications noted.It was communicated that the ¿over-cutting was slight and did not impact component positioning or final outcome¿.Based on the information provided, the patient impact was minimal and did not require additional interventions and the reported event did not impact the implant outcome; therefore, no additional patient impact would be anticipated.No further medical assessment is warranted 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: 11543955
• MDR Text Key: 241507611
• Report Number: 3010266064-2021-00220
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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: 07/25/2022
• 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