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

Model Number ROB10013

Device Problems Break (1069); Intermittent Continuity (1121); Connection Problem (2900); Material Split, Cut or Torn (4008)

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

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, when the burr was tried to load, there was an error message: "re- establish connection".Troubleshoot was tried (unplug the handpiece, switch off the cori system) but nothing worked.It was impossible to move beyond this screen.The procedure was completed with manual instrumentation.The patient was not harmed.

Manufacturer Narrative

H3, h6: the cori robotic drill rob10013, (b)(6), intended for use in treatment, was returned for evaluation.The external condition shows excessive signs of wear.The strain relief on the handpiece has been torn off all around the steel hub so that the individual wires are visible, some of which are visibly damaged (the thicker white and black without insulation).The reported problem cannot visually be confirmed.A functional test was completed, and the reported problem was confirmed.Although the error was not reproducible (due to an older software version used in the field), the reported symptoms would likely occur with the problems found during functional evaluation.A kpc test was attempted but failed all tests.The drill was taken apart for further investigation.It was found that the carriage and the lead nut screw were broken inside of the drill.The carriage and lead nut screw were replaced, but the drill still did not pass kpc tests.It was noted that the brown connecting wire of the exposure motor has been squeezed between the housing cap and the connection cap so that the bare wire is visible.With a broken exposure motor wire, the drill would fail kpc tests.The motors of the suspect drill were tested with a known good cable and passed all tests, pointing to the broken wire as the suspect of the failures.The most likely cause of this issue is due to a broken brown exposure motor wire and damaged lead screw nut and carriage.Review of manufacturing records found no related non-conformances or anomalies associated with this serial number during production.Review of service records prior to the complaint date for the reported device identified prior service.The service record indicated the device met all specifications following completion of the service activity.A review of manufacturing records 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.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual (500230 rev d).A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.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, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

H3, h6: the cori robotic drill rob10013, (b)(6), intended for use in treatment, was returned for evaluation.The external condition shows excessive signs of wear.The strain relief on the handpiece has been torn off all around the steel hub so that the individual wires are visible, some of which are visibly damaged (the thicker white and black without insulation).The reported problem cannot visually be confirmed.A functional test was completed, and the reported problem was confirmed.Although the error was not reproducible (due to an older software version used in the field), the reported symptoms would likely occur with the problems found during functional evaluation.A kpc test was attempted but failed all tests.The drill was taken apart for further investigation.It was found that the carriage and the lead nut screw were broken inside of the drill.The carriage and lead nut screw were replaced, but the drill still did not pass kpc tests.It was noted that the brown connecting wire of the exposure motor has been squeezed between the housing cap and the connection cap so that the bare wire is visible.With a broken exposure motor wire, the drill would fail kpc tests.The motors of the suspect drill were tested with a known good cable and passed all tests, pointing to the broken wire as the suspect of the failures.The most likely cause of this issue is due to a broken brown exposure motor wire and damaged lead screw nut and carriage.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.Review of manufacturing records found no related non-conformances or anomalies associated with this serial number during production.Review of service records prior to the complaint date for the reported device identified prior service.The service record indicated the device met all specifications following completion of the service activity.A review of manufacturing records 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.In the event of a system failure, refer to the recovery procedure guidelines in the real intelligence cori for knee arthroplasty user manual (500230 rev d).A failure can consist of, but is not limited to, a system software crash, unrecoverable hardware failure, handpiece failure with no backup available, tracker failure or loss of contact with bone that is unrecoverable, etc.The failure mode and associated risk have been anticipated within the risk file and the documented 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.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 g2 report source.

• 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: 16632360
• MDR Text Key: 312191155
• Report Number: 3010266064-2023-00059
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• 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: Unknown
• Removal/Correction Number: RES# 93620
• Patient Sequence Number: 1
• Treatment: ROB10024/REAL INTELLIGENCE CORI
• Patient Outcome(s): Required Intervention