MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKER CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/03/2021

Event Type  malfunction  

Event Description

It was reported that during cori legion cr tka procedure, they passed drill diagnostics prior to case creation and there were no errors leading up to distal femur cut.However, when entered distal femur cut screen, bur was not exposing past the guard ((b)(4)).About 7-10 seconds into this screen, with no bone being cut due to lack of bur exposure, a bad console error pops up on screen ((b)(4)).The peak plasma blade was in use during this case (at 8 and 6) though not actively cauterizing at the time of the distal cut.Began troubleshooting: initially exited case and immediately re-entered, but the 24 inch touchscreen was flickering ((b)(4)), so quit and exited the case and completely shut down the system.Upon restart, re-entered case without issue.Completed case through initial post-op gap assessment with cori, but then needed to recut tibia and could not replace cut block with tibia array in place (covered on (b)(4)), so removed array and completed re-cut and re-trialing manually.Delay reported of fewer than 30 minutes.

Manufacturer Narrative

H3, h6: the real intelligence robotic drill tracker rob10014 used in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be established.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.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 user manual provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, after device malfunctions and upon re-start, the surgeon was able to progress the cori case through the initial post-op gap assessment, ¿but then needed to recut tibia and could not replace cut block with tibia array in place, so removed array and completed re-cut and re-trialing manually¿.It was communicated that the ¿tibia array was placed intra-incisionally, which in this case happened to be too proximal to accommodate the tibial block during the recut¿ and ¿is not a complaint¿.The requested operative notes and x-rays were not provided.Since reverting to a manual procedure is an approved surgical technique and no patient injury was reported due to the events and/or the 0-30-minute surgical delay, no further patient impact would be anticipated.No further medical assessment is warranted at this time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE TRACKER CLAMP
• 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 ; 2905 northwest blvd ste 40; plymouth, MN 55441 ; 5123913905
• MDR Report Key: 11580333
• MDR Text Key: 242801276
• Report Number: 3010266064-2021-00235
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757338
• UDI-Public: 00885556757338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROB10014
• Device Catalogue Number: ROB10020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other