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

Model Number ROB10013

Device Problems Connection Problem (2900); Unintended Application Program Shut Down (4032)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during the set-up for a cori assisted tka surgery, a burr could not be locked into the real intelligence robotic drill and an internal error message and a communication error message were displayed.Surgery was performed with a sn back-up device, after a non-significant delay.The patient was not harmed as a consequence of this issue.

Manufacturer Narrative

Section h10: the cori drill, pn rob10013, (b)(6) used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported event.A functional evaluation was performed.The evaluation followed the cori drill performance verification.The reported problem was not confirmed.The handpiece performed as designed.A customer photo review was performed.The reported problem was confirmed.The photos confirm that the internal error message and a communication error message were displayed.Although the reported problem was confirmed with an image, there are multiple causes and the most likely cause of this event cannot be determined without additional evidence i.E.Log files.Additional evidence is required to arrive at a root cause and at the moment no reasonable contributing factors could be identified based on the received complaint information and investigation results.A review of manufacturing 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.Internal complaint reference number: case-(b)(4).

Manufacturer Narrative

Section h10: the cori drill, pn rob10013, sn (b)(6), used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.Nothing was identified visually that contributed to the reported event.A functional evaluation was performed.The evaluation followed the cori drill performance verification.The reported problem was not confirmed.The handpiece performed as designed.A customer photo review was performed.The reported problem was confirmed.The photos confirm that the internal error message and a communication error message were displayed.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.A review of manufacturing 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.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.Internal complaint reference number: (b)(4).

• 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: 15434302
• MDR Text Key: 304794079
• Report Number: 3010266064-2022-00604
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• 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: REAL INTELLIGENCE CORI, SN: (B)(6).