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

Catalog Number ROB10024

Device Problems Application Program Problem: Parameter Calculation Error (1449); Use of Device Problem (1670)

Patient Problems Laceration(s) (1946); Insufficient Information (4580)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka procedure, the console showed an over cutting on the lateral side of the tibia, after the surgeon created a shelf with the burr and debunked with the saw.The procedure was completed, without any delay.Further complications have not been reported.

Event Description

It was reported that, during a cori assisted tka procedure, the surgeon created a shelf with the burr and debunked with a saw.The tibia was overcut with the saw that the surgeon used to free hand.The plan was adjusted down 1.5 mm and used a cemented implant instead of a press fit tibia due to the overcut.The procedure was completed, without any delay with the same real intelligence cori.The patient is doing fine., further complications have not been reported.

Manufacturer Narrative

Additional information: b2 corrected data: b1, b5, h1 (type of reportable event), h6 (health effect - clinical code, health effect - impact code, medical device problem code).

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.Screenshots and system log files provided were reviewed.The reported problem with screenshots.The tibia bone removal screenshot shows the overcut.The most likely cause of this event is associated with the cutting technique.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing records indicate 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.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.

• 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: 19021535
• MDR Text Key: 339212219
• Report Number: 3010266064-2024-00076
• 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,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 03/13/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 05/01/2024
• Supplement Dates FDA Received: 04/08/2024; 05/02/2024
• 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
• Patient Outcome(s): Other; Required Intervention