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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

It was reported that, when the surgeon was smart mapping the femur during a cori ukr procedure, the surgeon released his foot from the pedal and the system was still capturing movement from the point probe and therefore collecting unwanted data points. This error was recovered by pressing the "release to stop" button on the screen. The surgeon was then able to go back and recollect his bone mesh of the femur at which point the error was resolved. There was a delay of fewer than 30 minutes. No patient was harmed and no other complications were reported.

• 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: 10875949
• MDR Text Key: 217414211
• Report Number: 3010266064-2020-02027
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse