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

Model Number ROB10013

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that during a cori tka procedure, the first robotic drill could not seat the bur in the carriage. They swapped to another robotic drill that did not seem to mill as it should, even though they did not receive any errors. It did not appear to be cutting bone efficiently. The bone was very hard and the surgeon moved between making saw cuts and cleaning up cuts with bur, but it did not appear to cut much. There was a change to manual procedure and a delay greater than 30 minutes. No other complications have been reported.

• 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: rick confer ; 2828 liberty avenue; suite 100, PA 15222
• MDR Report Key: 10514153
• MDR Text Key: 206312267
• Report Number: 3010266064-2020-01754
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• 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

Patient Treatment Data

Date Received: 09/10/2020 Patient Sequence Number: 1