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); Unintended Application Program Shut Down (4032)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

Upon a real intelligence robotic drill registration, the bur testing screen was successful but after hitting "continue" there was a ¿retraction time verification error¿.The handpiece was unplugged and the console was rebooted.A new case was opened and register was attempted again.Once in the unlock drill screen, the drill would not unlock and they got a message saying ¿communication failure¿.After several attempts, the issue was resolved by switching the handpiece.As this happened in a marketing demonstration, there was no patient involvement.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the ri robotic drill, part number rob10013, serial number (b)(6)., intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported retraction time failure was confirmed.The reported communication failure was not confirmed, and the drill was received with no attachment locked on.Wiping down the carriage with a h2o2 wipe resolved the retraction time failure.The most likely cause of these events is the over application of vacuum grease during handpiece assembly.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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

Manufacturer Narrative

H10: h3, h6: the ri robotic drill, part number (b)(4), serial number (b)(6), intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported retraction time failure was confirmed.The reported communication failure was not confirmed, and the drill was received with no attachment locked on.Wiping down the carriage with a h2o2 wipe resolved the retraction time failure.The most likely cause of these events is the over application of vacuum grease during handpiece assembly.Another factor 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.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.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.According to document, it states to lube.343¿ id o-ring with vacuum grease and install into the outer groove on carriage.Remove any excess grease after installing with a swab or lint free wipe.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.H11: corrected data updated section h6.

• 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: 15467880
• MDR Text Key: 302175340
• Report Number: 3010266064-2022-00609
• Device Sequence Number: 1
• Product Code: OLO
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: PN: ROB10024/SN: SN000216