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

Model Number ROB10024

Device Problem Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

It was reported that, during tibial collection on a cori ukr procedure, the mesh was not generating (despite full visibility of all trackers/flat markers, point probe, etc.).The foot was removed from the pedal to manually press collect on the tablet, which immediately started working.They re-attempted collection with foot pedal, and it continued to work after this was performed.There was a delay of less than 30 minutes, and no other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the device used for treatment was not returned to the designated complaint unit for evaluation therefore a visual or functional inspection could not be performed and the reported problem could not be visually or functional confirmed.A screenshot review was completed.The reported event was confirmed.A screenshot review revealed the tibia bone mesh was not present during free point collection.The most likely cause of this event is a known software bug that affects bone mesh generation.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.As a part of corrective action, an update to the software has been released to resolve this issue.

• 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
• MDR Report Key: 10692129
• MDR Text Key: 211752978
• Report Number: 3010266064-2020-01885
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1