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 Unspecified Tissue Injury (4559)

Event Date 03/21/2022

Event Type  Injury  

Event Description

It was reported that, during cori assisted tka, the anterior femur was notched by 3mms. The surgeon used the bur distal approach with punch tool then placed the size 4 cutting block, but the system sized for a size 5. They adjusted the gaps and resection to appropriate position, but the anterior cut was below the implant flange and conservative. Final planning screen showed an aggressive but 0. 5 mm into notch warning anterior cut (the surgeon used a wide angle sawblade). Initially, the femur trial would not fit and surgeon had to put on the size 4 cutting block again to check the cuts. They were still able to move more bone, but trial did not sit flush.

Manufacturer Narrative

Internal complaint reference:(b)(6).

• 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: 14104617
• MDR Text Key: 289207973
• Report Number: 3010266064-2022-00282
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• 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

Patient Treatment Data

Date Received: 04/13/2022 Patient Sequence Number: 1