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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that, during a demonstration with a real intelligence cori, after correct registration and planning, they wanted to drill the peg holes for tibia cutting block.The speed mode was selected, they removed the bur guard and pressed on the orange foot pedal to activate the drill and bur the holes.It was noticed that the drill was spinning and removed bone on the femur or other areas of the tibia where it was supposed not to spin.Since this was noticed during a demonstration, there was not any patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).

Manufacturer Narrative

Section h10: a video of the real intelligence cori, part #: rob10024, serial #: (b)(6) was provided for evaluation.A relationship between the reported event and the device was established.Functional evaluation could not be performed, device not returned.An investigation was performed on a similar device from a different lot.This event was reproduced using cori console sn(b)(6) and was found that the bur would spin when the tip is within 20mm of white bone.This occurred in bur all mode as well as when drilling peg holes.This is an intended function and it is the responsibility of the user to protect the femur from accidental over-cut when performing cutting of the tibia.An additional investigation was performed for the provided video.A review of the video provided showed that the bur was spinning when above the tibia and was able to cut the femur when in speed mode for drilling the tibia peg holes.The real intelligence cori for knee arthroplasty user manual states on page 120 under 'removing tibia bone' the following: "it is possible to cut the femur while in bone removal - tibia screen.Take care to protect the femur from over-cut while preparing the tibial surface.The exposure and speed controls will only work on the tibia, not the femur, while in the bone removal - tibia screen." an additional investigation was performed for the functionality of the speed control profile.A discussion on the speed control profile provided that the pfs controller has a linear ramping range from 0-100% speed between 0-1mm of bone-bur distance.The speed is maintained at 100% from 1-20mm and turns off to 0% past 20mm.The cause was found to be user related.Symptoms described in this reported event are intended functions of the cori console and have been outlined within the user manual.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.The product was not returned and no evidence was made available to link the complaint to an escalation event.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Internal complaint reference number: (b)(4).

• 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: 16005730
• MDR Text Key: 306907223
• Report Number: 3010266064-2022-00673
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• 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?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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