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

Model Number ROB10015

Device Problems Failure to Calibrate (2440); Physical Resistance/Sticking (4012)

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

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, while milling the femur in a cori assisted tka surgery, the robotic drill time out message was displayed.They re-calibrated the drill but the drill would not hold the 6mm bur in position.They resumed the operation and disconnected the drill to access the admin screen to release the drill tracker array but this failed as the real intelligence robotic drill would not unlock the drill attachment.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.Additionally, during calibration the drill showed 26 usages, while in the admin screen it showed 31 usages.

Manufacturer Narrative

B5 (event description), d1, d4, d10 (product information), g4 (510k), h6.

Event Description

It was reported that, while milling the femur in a cori assisted tka surgery, the robotic drill time out message was displayed.They re-calibrated the drill but the drill would not hold the 6mm bur in position.They resumed the operation and disconnected the drill to access the admin screen to release the drill tracker array but this failed as the real intelligence robotic drill would not unlock the drill attachment.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.Additionally, during calibration the drill showed 26 usages, while in the admin screen it showed 31 usages.After procedure was completed, sales rep persisted on releasing the devices, and at the 8th attempt all the devices were able to released.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill, part number rob10013, serial number (b)(6)., used for treatment, was returned for evaluation, along with pictures of the event.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.Across multiple diagnostic tests and test cases, the drill would sometimes fail with system time out errors, leaving the drill attachment in an unremovable state.Substituting the exposure motor led to more consistent passed tests.The problem of misrepresenting the drill usage was not confirmed.The drill appeared as 31 uses both in admin diagnostics and during a test case.A relationship between the reported event and the device was established.The most likely cause of this event is an intermittent faulty exposure motor connection.Refer to the real intelligence cori for knee arthroplasty user manual, section connecting the robotic drill and verifying the robotic drill for proper set up and calibration.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.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Further investigation into the reported failure is being conducted to determine if additional escalation actions are required.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), used for treatment, was returned for evaluation, along with pictures of the event.The reported problem could not be confirmed with a visual inspection.The reported problem was confirmed with a functional evaluation.Across multiple diagnostic tests and test cases, the drill would sometimes fail with system time out errors, leaving the drill attachment in an unremovable state.Substituting the exposure motor led to more consistent passed tests.The problem of misrepresenting the drill usage was not confirmed.The drill appeared as 31 uses both in admin diagnostics and during a test case.A relationship between the reported event and the device was established.The most likely cause of this event is associated with a 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.Refer to the real intelligence cori for knee arthroplasty user manual, section connecting the robotic drill and verifying the robotic drill for proper set up and calibration.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.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.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.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: 15353025
• MDR Text Key: 299269024
• Report Number: 3010266064-2022-00594
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 09/14/2022; 11/24/2022; 01/30/2024
• Supplement Dates FDA Received: 09/22/2022; 11/29/2022; 01/30/2024
• 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: Reuse
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: PN:ROB10014/SN:UNKNOWN; PN:ROB10015/SN:(B)(6); PN:ROB10024/SN: (B)(6)
• Patient Outcome(s): Required Intervention