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

Catalog Number	ROB10024
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during set up for a cori assisted tka surgery, the real intelligence robotic drill had a communication failure at unlock screen, followed by internal error when exiting case.They proceeded to created a new case, but could not clear.They tried to restart the system but the issue persisted.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), used for treatment, was not returned for evaluation.The reported problem could not be confirmed with a visual or functional evaluation due to the device not being returned.A review of relevant log files and screenshots was performed.The communication failure at the unlock screen was confirmed.As this error is classified as unrecoverable, the case was automatically aborted and an internal error presented.This type of error occurred multiple times with the drill initially used on this day.A relationship between the reported event and the device was established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a faulty encoder connection in the exposure motor drill.The drill was received for testing and issues found.A review of manufacturing 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 historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE CORI
• Common Device Name: 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: 12701395
• Report Number: 3010266064-2021-00731
• Device Sequence Number: 1466997
• Product Code: OLO
• UDI-Device Identifier: 00885556773673
• UDI-Public: 885556773673
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 01/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown