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 03/14/2022

Event Type  malfunction  

Event Description

It was reported that during a cori assisted tka surgery, surgeon said it looked like it was airballing even though they were two clicks into the notch warning. Surgeon was painting thoroughly on the anterior cortex both medially and laterally directly with the tip of the point probe (he might have been a bit posterior on his tibial point collection). The procedure was completed, without delay, using the same device. There was not any additional or unintended cuts performed (cuts were to plan). Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: case(b)(4).

• 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: 14007488
• MDR Text Key: 288589299
• Report Number: 3010266064-2022-00248
• Device Sequence Number: 1
• Product Code: OLO
• 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: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/05/2022
• 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
• Date Manufacturer Received: 03/14/2022
• 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: Unkown