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 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, following gap data collection in a cori assisted tka surgery, the gap data was not visible on the planning screen.Furthermore, the button to toggle on and off the gap graphs was unable to be pushed.They recollected the gap data and progressed to the planning screen and had the same issue.They exited the case, resumed the case, recollected the gap data, and were still unable to see the graphs on the implant planning screen.They exited the case and started a completely new case and following the gap data collection, they could still not see the data on the planning screen.The button to toggle on the graph was still unavailable.They checked the checkpoints and nothing had moved.They slightly altered the positioning of the implant (added 1 degree of varus) and rechecked the gaps.Once they did that and went back to the implant planning screen, the graph was available.The procedure was completed with the same device without significant delays.The patient was not harmed.

Manufacturer Narrative

Section h3, h6: the real intelligence cori, pn: rob10024, sn: (b)(4) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The screenshots were not provided for review, and the log files provided do not provide information that could confirm and/or identify the cause of the non-visible gap data in the planning screen.Although the reported complaint could not be confirmed, the most likely cause for the non-visible gap graph would be due to insufficient gap data collected, resulting in no gap data in the combined planning screen.The combined planning stage will display graphs only if at least one data point is collected in the range of -10 to 50 degrees, and one data point collected in the range of 50 to 110 degrees.Refer to the ¿performing gap assessment¿ section of the real intelligence cori for knee arthroplasty user manual (500230).This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the documented risk file requires further investigation and possible adjustment by the site quality team.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.

• 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: 12538068
• MDR Text Key: 273601686
• Report Number: 3010266064-2021-00669
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• 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: Unknown
• Patient Sequence Number: 1