MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problem Mechanical Jam (2983)

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

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during set up for a cori assisted surgery, the real intelligence cori was used to create a case, they plugged the drill in and immediately received a critical internal error ((b)(4)). They were unable to quit the case so they proceeded to shut down the unit via the power switch in the back. Then they realized that the ri robotic drill attachment had gotten jammed in the real intelligence robotic drill ((b)(4)). They attempted to unlock the ri robotic drill attachment by using the robotic drill diagnostic application and also by creating a test case neither method were successful ((b)(4)). They didn¿t have any other trays available, so the surgeon did the case with standard instrumentation. The procedure was completed, with a non-significant delay, by changing in surgical technique. Patient was not harmed beyond the problem reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during set up for a cori assisted surgery, the real intelligence cori was used to create a case, they plugged the drill in and immediately received a critical internal error ((b)(4)). They were unable to quit the case so they proceeded to shut down the unit via the power switch in the back. Then they realized that the ri robotic drill attachment had gotten jammed in the real intelligence robotic drill ((b)(4)). They attempted to unlock the ri robotic drill attachment by using the robotic drill diagnostic application and also by creating a test case neither method were successful ((b)(4)). They didn¿t have any other trays available, so the surgeon did the case with standard instrumentation. The procedure was completed, with a non-significant delay, by changing in surgical technique. Patient was not harmed beyond the problem reported.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 12912259
• MDR Text Key: 285222150
• Report Number: 3010266064-2021-00837
• Device Sequence Number: 1
• Product Code: OLO
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• 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