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

Model Number ROB10013

Device Problem Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that, during tka cori procedure, while patient under anesthesia when surgeon started to cut femur with handpiece the handpiece disconnect error occurred.The surgeon could not troubleshoot because the burr would not come out or unlock so he was unable to calibrate.Due to time constraint he went to a manual procedure.Delay less than 30 minutes reported.No patient harm was reported.

Manufacturer Narrative

H3, h6: the cori drill p/n: rob10013, sn: (b)(6) used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was performed and the test passed.The reported problem was not confirmed.The drill functioned as expected without any connection issues.A engineering evaluation was performed.The drill functioned as intended.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 has identified prior events.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, no further containment or corrective action is recommended or required at this time.

Manufacturer Narrative

H3, h6, h7: the cori drill p/n rob10013, (b)(6) used for treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was performed and the test passed.The reported problem was not confirmed.The drill functioned as expected without any connection issues.A engineering evaluation was performed.The drill functioned as intended.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 has identified prior events.The real intelligence cori for knee arthroplasty user manual (500230 rev d) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that the lot, serial number or part number reported in this event is related to a corrective/preventive action already implemented.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may be associated with an intermittent failure of the drill exposure motor due to the thermo-mechanical stress induced within the motor at the encoder and electrical noise on the console error status inputs to the drill exposure motor encoder.Continuous improvements have been made to the cori robotic drill and manufacturing processes to reduce drill disconnection error messages.These improvements consisted of: 1.A hardware update to the cori console to reduce noise on the internal electronics.2.An update to the cori system¿s software and firmware to improve the user experience when error messages are displayed, and 3.A hardware update to the cori drill to reduce mechanical stress on drill exposure the motor.The first two improvements are fully deployed.The third improvement is being deployed for new orders and as drills are returned for routine servicing.Also, smith+nephew is voluntarily performing a recall/field notification for the cori real intelligence robotic drill.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 ROBOTIC DRILL
• 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; suite 100; austin, TX 78735 ; 5123913905
• MDR Report Key: 10711370
• MDR Text Key: 212306564
• Report Number: 3010266064-2020-01921
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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