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

Model Number ROB10024

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported that, during a cori assisted tka surgery, following the bone resection phase, the surgeon conducted a trial reduction with trial instruments and noticed the extension gap and flexion gaps were off.The issue of the incorrect bone resections according to the intra-operative plan could not be solved.To compensate, the surgeon used the cement mantle to align the femoral component into an acceptable position so that the achieved patients leg alignment was closer to the planned leg alignment.The surgeon only discovered after the procedure, when he printed off the patient report from the cori system, that an incorrect implant had been selected at the start of the procedure, a gii was selected instead of legion, and as he had planned to implant a legion knee he was under the impression he was planning and executing for a legion knee.This was the root cause of the issue.Patient's current health status is unknown.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.Cori is a surgical tool designed to provide assistance to the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon is responsible for implant planning and the conduct of the surgery during which cori is being used.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with the result of an incorrect implant selection.Based on the investigation, the need for a corrective action is not 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: 13938743
• MDR Text Key: 288106843
• Report Number: 3010266064-2022-00225
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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 Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/10/2022
• 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
• Patient Outcome(s): Required Intervention