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

Model Number ROB10013

Device Problems Retraction Problem (1536); Connection Problem (2900); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during the drill diagnostics test in a cori assisted tka surgery, the real intelligence robotic drill failed minimum homing torque 3/4 times.They went to get a back up drill.In the meantime, they tried to start the case and as soon they hit unlock they received a system time out error.They hit continue a few times and received the same error.They quit, reboot the system, unplugged it, started a new case, and received the same system time out error.At this point the other drill became available, but they could not disassemble the drill.The procedure was completed with manual instrumentation with a 5 minutes delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

The real intelligence robotic drill, part number rob10013, s/n (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.An analysis of the customer provided log files could not be assessed as the log files could not be accessed.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 completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the product instructions for use ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure is an identified failure mode within the risk assessment.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc test was run and the drill passed with no errors.A case was run and the drill functioned without any issues or errors.Although the reported problem was not confirmed factors that may have contributed to the reported symptom may have been associated with another device used as part of the system.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, s/n (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device could not be established.An analysis of the customer provided log files could not be assessed as the log files could not be accessed.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.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Refer to the product instructions for use ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure is an identified failure mode within the risk assessment.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.A kpc test was run and the drill passed with no errors.A case was run and the drill functioned without any issues or errors.Although the reported problem was not confirmed through a visual or functional evaluation, 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12548222
• MDR Text Key: 273826494
• Report Number: 3010266064-2021-00689
• 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: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention