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 06/21/2021

Event Type  malfunction  

Event Description

It was reported that during a cori assisted ukr surgery, while registration, upon landing on the ¿femur kinematic axis¿ page, a warning message was prompted, stating the kinematic axis was collected incorrectly and may be inaccurate.Then, they pressed ¿ok¿ to resolve the issue by recapturing the kinematic axis again.The system allowed them to proceed to the ¿hip center calculation¿ screen and they received an error of 0.7, which was then automatically prompted to the next screen ¿femur neutral position¿.After collecting the neutral position, they were prompted with another error message warning that they recollect hip center.They recollected hip center and this error was prompted again.After collecting hip center again, they were able to collect the kinematic axis and their stressed rom.The procedure was completed with a delay of less than 30 minutes, using the same device, following the prompts and continuing with the recollection of hip center until system allowed user to proceed with the case.Patient was not harmed as consequence of this 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.Although the product was not returned the software files were downloaded from the device and provided for investigation.Screenshot review confirmed that the user received two ¿incorrect kinematic axis¿ warning messages, however, the log files do not indicate any system or software issue related to the reported complaint.The log files indicate the kinematic axis check failed with an angle greater than 10 degrees for both kinematic axis failure.The kinematic axis shall be within 10 degrees of normal to the long axis for a ukr case.After incurring the ¿incorrect kinematic axis¿ error, the user is prompted with the option to either: ¿re-collect native rom,¿ ¿re-collect hip center,¿ or to ¿proceed anyway.¿ the log files also indicate that the user had chosen to recollect the neutral position (native rom), and the kinematic axis again failed with a greater than 10 degree angle relative to the normal.The user then selected the ¿re-collect hip center¿ option, where they then passed with an angle of 7.8 degrees.As a result of these findings, it was determined that the software functioned as intended; no defect of the system occurred.It is possible that the user had applied stressed to the knee when collecting the femur kinematic axis range that resulted in a greater than 10 degree discrepancy between the knee¿s kinematic axis and long leg axis.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: 12114827
• MDR Text Key: 261476519
• Report Number: 3010266064-2021-00509
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 10/07/2022
• 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: A
• Patient Sequence Number: 1