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 Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka procedure, following standard setup, registration and planning, surgeon began the distal cut and noticed some red indication of over cutting.When surgeon moved drill away from knee noticed the bur was no longer sitting flush with the guard but come out of the drill.Surgeon recalibrated the drill to reinstall bur and this worked and remaining distal cut functioned correctly.This error in over cutting caused a several mm defect on the distal medial condyle.Then, he recut distal additional 2+ mm and still had a defect medial.After making other cuts look at with the bur all screen and he noted a 3-4 mm defect remaining on 50% of distal medial condyle.The robotic drill was used to complete the distal cut then the surgeon placed on the 5 in 1 block and manually moved it 2 mm anterior to balance flexion with additional distal cut.The surgeon used bone from chamfer cut to graft the space and took no other measure as final component was stable.Procedure was completed with a delay greater than 30 minutes and with a back-up drill.The patient was not harmed beyond the reported problem.

Event Description

It was reported that, during a cori assisted tka procedure, following standard setup, registration and planning, surgeon began the distal cut and noticed some red indication of over cutting.When surgeon moved drill away from knee noticed the bur was no longer sitting flush with the guard but come out of the drill.Surgeon recalibrated the drill to reinstall bur and this worked and remaining distal cut functioned correctly.This error in over cutting caused a several mm defect on the distal medial condyle.Then, he recut distal additional 2+ mm and still had a defect medial.After making other cuts look at with the bur all screen and he noted a 3-4 mm defect remaining on 50% of distal medial condyle.The robotic drill was used to complete the distal cut, then the surgeon placed on the 5 in 1 block and manually moved it 2 mm anterior to balance flexion with additional distal cut.The surgeon used bone from chamfer cut to graft the space and took no other measure as final component was stable.The surgeon was satisfied with the outcome.Procedure was completed with cori with a delay greater than 30 minutes.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

B5, h6.

Manufacturer Narrative

The real intelligence cori, part number: rob10024, serial number: (b)(6), used for treatment, was not returned for evaluation.The reported problem could not be confirmed with a visual inspection.A functional evaluation could not be performed due to the device not being returned.An image was provided.Screenshots were sent in with the field report.A review of the relevant screenshots shows an initial overcut on the edge of the medial condyle.There was an attempt to correct this by resecting more of distal femur, but the defect still remained and required a graft of the chamfer cut bone.A relationship between the reported event and the device was established.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a software bug causing overcuts near bone edges while in exposure mode.This was most likely exacerbated by the burr not being locked properly and extending past the drill guard.The clinical/medical investigation concluded that based on the documentation provided, the root cause of the reported event cannot be concluded.Although the field report indicated ¿n/a to recover¿, the surgeon did manually move the cutting block anteriorly to balance flexion with additional distal/¿other¿ cuts and filled the medial condyle space with ¿bone from chamfer cut to graft the space and took no other measure as final component was stable¿ which resulted in a >30 minute surgical delay.The patient impact beyond the reported over-burring, additional cuts, grafting with chamfer-cut bone, greater than 30-minute surgical extension and modified surgical procedure could not be determined.No further medical assessment can be rendered at this time.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.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.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: 14973823
• MDR Text Key: 295600875
• Report Number: 3010266064-2022-00519
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• 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
• Date Manufacturer Received: 11/23/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention