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

Model Number ROB10013

Device Problems Overheating of Device (1437); Retraction Problem (1536); Connection Problem (2900); Noise, Audible (3273)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during machine setup for a cori assisted surgery, the warning "retraction time verification error" popped on the screen.After clicking on ok the error system time out popped.The kpc testing failed and the real intelligence robotic drill got extremely heated and gave out a high pitched noise.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.

Manufacturer Narrative

H3, h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the real intelligence robotic drill, part number rob10013, serial number (b)(6), intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a loose internal connector, and/or internal motor performance degradation or failure.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.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6)intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.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: 14655087
• MDR Text Key: 295347697
• Report Number: 3010266064-2022-00472
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• 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
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA, SN:(B)(4)