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

Model Number ROB10013

Device Problems Unstable (1667); Connection Problem (2900)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2021

Event Type  Injury  

Event Description

It was reported that during a cori assisted tka surgery, the real intelligence robotic drill had a disconnect error. They proceeded to quit, unplugged, re-plugged and calibrate the same device and were able to continue. During this surgery, the bur had jumped and taken extra bone in the eminence ridge upon implantation and trialing. The surgeon put a 2-3mm gap stick in the joint space of the medial compartment. Upon forcing the leg into extension the tib bone fractured. They were unsure if this fracture was from the "extra bone" taken from the bur. They did end up explanting all implants and converting to a total. The procedure was completed, with a minimal delay (fewer than 30 minutes) using the same device. No patient injuries and no other complications were 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: 11891117
• MDR Text Key: 252901833
• Report Number: 3010266064-2021-00421
• 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,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• 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: Unkown

Patient Treatment Data

Date Received: 05/26/2021 Patient Sequence Number: 1