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 Problems Laceration(s) (1946); Perforation (2001)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

H10.Internal reference number: (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, after distal femur burr the surgeon placed cutting block into his drilled lug holes.He placed plan visualizer however found rotation to be off by about 3 degrees and when he tried to correct he found it looked as thought he was internally rotating.Tried to use manual a-p sizer however when he tried to pin this he was running into femur pins of clamp holding femur array.We tried to drill other lug holes and replace cutting block, but ultimately this did not work either.Ended up choosing to burr all for remaining femur.Kept coris size for femur.He seemed pleased with post op rom and gaps.The surgery was completed, after a significant delay, with the same reported device.No injuries were reported.

Manufacturer Narrative

H3, h6: the real intelligence cori, rob10024, (b)(6) used for treatment, was not returned for evaluation therefore a visual and functional inspection could not be performed.The reported problem could not be visually or functionally confirmed.Screenshots and system log files provided were reviewed with the clinical support team.The reported problem was not confirmed.The screenshots did not capture the plane visualizer being utilized or showing a rotation of 3 degrees.Only two screenshots of the femur burring were shown, and it could be seen that there was some green left on the femur, showing that 1mm or less of bone still needed removed.This could cause the cut block to not sit flush on the femur, which could explain the plane visualizer appearing rotated.Although the reported problem was not confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated with leaving behind green bone on the femur.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was not completed.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.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 and the documented risk level is still adequate.Based on the limited documentation provided, no clinical factors have been identified which would have contributed to the reported event.It is unknown if the user manual was adhered to, and it cannot be concluded that there was a malperformance of the system components.The patient impact included a significant surgical delay of greater than 30 minutes with drilling of additional lug/bone holes and change of technique from distal femur cut guide to burr-all.It was communicated that the current patient status is stable after ¿a successful surgery¿.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Event Description

It was reported that, during a cori assisted tka surgery, after distal femur burr the surgeon placed cutting block into his drilled lug holes.He placed plan visualizer however found rotation to be off by about 3 degrees and when he tried to correct he found it looked as thought he was internally rotating.Tried to use manual a-p sizer however when he tried to pin this he was running into femur pins of clamp holding femur array.We tried to drill other lug holes and replace cutting block, but ultimately this did not work either.Ended up choosing to burr all for remaining femur.Kept coris size for femur.Surgeon seemed pleased with post op rom and gaps.The surgery was completed, after a delay greater than 30 min, with the same reported device.No injuries were reported, patient is stable.

• 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: 18368507
• MDR Text Key: 331025587
• Report Number: 3010266064-2023-00237
• Device Sequence Number: 1
• Product Code: OLO
• 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: 02/26/2024

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: 11/28/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization