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

Model Number ROB10024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  Injury  

Event Description

It was reported that, during a cori-assisted tka surgery, the surgeon accepted a notch warning.Surgeon advised to proceed.Surgeon notched the femur and bailed to a revision tka.The procedure was completed with manual instrumentation.The patient outcome is unknown.

Event Description

It was reported that, during a cori-assisted tka surgery, the surgeon accepted a notch warning.Surgeon advised to proceed.Surgeon notched the femur and bailed to a revision tka to stabilize the knee joint after notching the femur.The procedure was completed with manual instrumentation without significant delays.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was returned to the designated complaint unit for evaluation.Nothing was identified visually or functionally that contributed to the reported issue.The software files were downloaded from the device and provided for investigation.The screenshots were reviewed with clinical account representatives and confirmed the notch warning in the implant planning screen prior to cutting.Therefore, when the user removed the bone, the system operated as intended and burred to plan.The real intelligence cori for knee arthroplasty user manual states that cori defines notching by calculating the trajectory of the anterior cut 20 mm superior to the most superior portion of the anterior aspect of the implant.It also instructs the user to verify the implant component is not notching anteriorly into the digitized bone surface.If cori detects implant notching, the symbol appears.The real intelligence cori for knee arthroplasty user manual (500230) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The clinical/medical evaluation concluded: ¿based on the information provided, the root cause of the reported event was user technique.The patient impact beyond the reported femoral notching, subsequent modified surgical procedure to revision components, and the 0-30 minute surgical extension could not be determined.It was reported that the procedure was successfully completed using standardized instrumentation with an unknown patient outcome.No further medical assessment can be rendered at this time.Should a product/engineering evaluation conclusion result in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.¿.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.

• 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: 12294601
• MDR Text Key: 265608320
• Report Number: 3010266064-2021-00585
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention