MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10024

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 04/04/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a cori assisted tka surgery, the surgeon questioned the accuracy with the femoral sizing on the tka application on cori.He planned for a size 8 femur, he then burred the distal femur, and then upon placing the 5-1 block he realized that he was barely taking any bone off the anterior flange and realized that the patient anatomy was calling for a size 7 femur rather than a size 8.He ended up placing a size 7 5-1 block instead of the size 8 and proceeded with the case.It is unknown if the procedure was completed with robotic assistance.No delay was reported.Patient was not injured as consequence of this problem.

Event Description

It was reported that, during a cori-assisted tka surgery, the accuracy with the femoral sizing on the tka application on cori was questioned.Even though a size 8 femur was planned for, when the distal femur was burred and then upon placing the 5-1 block, it was noticed that any bone was barely being taken off the anterior flange and that the patient¿s anatomy was calling for a size 7 femur rather than a size 8.A size 7 5-1 block ended up being placed instead of the size 8.The procedure was resumed using robotic assistance and the same console, after no delay.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6) , used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.The submitted log files were empty.Should usable screen shot and system log files become available, the case can be reopened.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicates the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with landmark and point collection.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received, the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post-market surveillance activities.H11- corrected data b5- describe event or problem.

• 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: 19093078
• MDR Text Key: 340689164
• Report Number: 3010266064-2024-00086
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1