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 case (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, the settings were set to pca, the surgeon mapped the femur and tibia, there was a 7 degree varus deformity, and the real intelligence cori did not prompt them to redefined femoral axis.The surgeon was questioning the consistency of cori as he was told that the threshold for redefining is 7 degrees of varus.They redefine manually on the femoral mapping screen by clicking the redefine axis button.The procedure was completed with the same device without delay.The patient was not harmed.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: 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.Although the product was not returned the software files were downloaded from the device and provided for investigation.The log files do not indicate any system or software issue related to the reported complaint.Screenshots confirmed the pre-operative alignment of 7 degrees varus.The cori user¿s manual says the alignment needs to be outside of this range to have the femur axis manually defined, therefore the system operated as intended.The most likely cause of the reported complaint was the different interpretation of the manual collection of the femoral rotational axis as defined in the cori user's manual.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 and that the documented risk level is still adequate.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.Corrected data: g2.

• 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: 12538087
• MDR Text Key: 273550876
• Report Number: 3010266064-2021-00670
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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: 04/28/2022
• 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