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 11/22/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted ukr surgery while burring the femur in exposure mode, bur overcut bone by 6-8mm.They proceeded to reassembled same bur within drill after unlocking and locking attachment and continue without issue.They suspect the edge of bur caught on hard bone and was dislodged from the assemble ((b)(4)).The surgeon filled in defect with cement.The procedure was completed, with a non-significant delay, using the same device.The post-op rom and alignment and sizing were as planned.After surgery, they were unable to disassemble ri robotic drill attachment from the drill.They went into drill diagnostics, unlocked collet, and were able to remove the attachment ((b)(4)).

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

The real intelligence cori, part number rob10013, serial number (b)(6), used for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device was established.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported ¿burr overcut 6-8mm while burring the femur in exposure mode,¿ cannot be definitively concluded.However, a user technique cannot be ruled out as a potential contributing factor.The reported problem was confirmed with a visual inspection.The image provided confirms there was an overcut of the bone.No log files were provided.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the removing femur and tibia bone section in the real intelligence cori for knee arthroplasty user manual.Exposure control mode with the bur working perpendicular to the cutting surface is recommended for easily accessible areas that are unrestricted by boney anatomy.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with an inappropriately secured burr.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: 12975676
• MDR Text Key: 282054530
• Report Number: 3010266064-2021-00862
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/21/2022
• 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: A
• Patient Sequence Number: 1