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

Catalog Number	ROB10024
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka surgery with coriograph, the femur model was unable to populate while collecting data points.The model would jump between looking like a lot is filled in, back to missing multiple places with critical blue areas.More then enough data should have been provided for the model to generate.After the surgeon decided to convert to an image less procedure the model appeared to generate with all the data collected, showing a normal femur model.The surgery was completed, after a non-significant delay, with the same reported device.No injuries were reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The faulty device is a coriograph pre-op services, part number: rob20030, and this failure mode is not reportable for this device.Mismatches or discrepancies identified during the registration or planning phase can typically be resolved quickly with minimal disruption to the surgical workflow.Event may result in a short procedural delay and/or continue with an image-free procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable pursuant to applicable regulations.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• 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: 20031656
• Report Number: 3010266064-2024-00172
• Device Sequence Number: 11531936
• Product Code: OLO
• UDI-Device Identifier: 00885556917442
• UDI-Public: 885556917442
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 07/31/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/05/2024
• 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