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

Model Number ROB10015

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that after the registration of the femur in a cori assisted tka surgery, an error message was displayed noting that the real intelligence robotic drill was disconnected. After they reset a few times they completed the procedure with manual instrumentation without significant delays. The patient was not harmed beyond the reported problem. Additionally, it was impossible to disconnect the ri robotic drill attachment from the drill. They tried to reset and start a new case, but it did not help; they also cleaned the end of the drill and the connection in the console. The root cause of this issue is an out-of-specification nut on the drill attachment, which makes it a reportable event.

• 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: 12972225
• MDR Text Key: 282624279
• Report Number: 3010266064-2021-00856
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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