MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10025

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, while mapping the femur in a cori sawbones demo, they received an error saying: "camera disconnected re-establish connections and press continue to reinitialize the tracking system". They pressed continue and received the following error: "camera failed to reinitialize". They press continue to try again. They went to check the ethernet cable and observed two solid red lights on the back of the camera. They exited the case, swapped ethernet cables, and when they got to the connection screen, the camera would not connect. They powered down the system and rebooted it. When they got back to the connection screen, the camera was able to connect. However once again, when they painted the femur the camera had the same set of errors as described above. Quality recommended resetting the shock sensor. They attempted to perform this; however, when they were in the code input screen, the console was unable to connect with the camera. It said "searching for devices. Error: cannot fins any device". They restarted the system and tried this again and received the same error. Finally they attempted to get through registration as quickly as possible to see if they could get to the planning screen. They were able to do this and the camera did not go down. They even collected joint laxity and burred the distal femur. After that, they opened a uka case and went through the entire workflow except for cutting. No case involved; therefore, there was no patient involvement. It is unknown if the issue is from camera or console.

• Brand Name: REAL INTELLIGENCE TRACKING CAMERA
• 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: 13957675
• MDR Text Key: 288281230
• Report Number: 3010266064-2022-00233
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757437
• UDI-Public: 00885556757437
• 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: Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10025
• Device Catalogue Number: ROB10025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown