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

Model Number ROB10013

Device Problems Overheating of Device (1437); Noise, Audible (3273); Physical Resistance/Sticking (4012)

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

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that during a cori assisted tka surgery, when burring the femur, the real intelligence robotic drill began making a screaming sound and was also becoming overheated at this same point in time. Eventually the real intelligence robotic drill stopped working. Then, the ri robotic drill attachment and the real intelligence robotic drill tracker got stuck on the real intelligence robotic drill. The procedure was completed, with a non-significant delay, using a s+n back-up devices. Patient was not harmed beyond the problem 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13501924
• MDR Text Key: 285761055
• Report Number: 3010266064-2022-00089
• 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: Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown