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

Model Number ROB10013

Device Problem Suction Problem (2170)

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

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Our reference number: (b)(4).

Event Description

It was reported that during a cori tka procedure, there¿s bone debris occurring during bone milling of femur and tibia.Prior to the case today, it was stated that bone debris has been found in between machines/equipment/carts in the or where cori has been used.It was stated that debris was observed flying off sterile field into the air, touching ceiling, lights, equipment, etc.At previous case and they¿ve been demanding more coverage and a barrier.Because of these statements, the drape was raised higher and an extra drape was also placed at the head of the patient, as well as a longer clear drape to further drape out anesthesia and equipment.They also covered the tower/cart for the bovie because there were complaints of found debris after last case.Regardless of extra draping precautions, bone debris was still observed.The doctor mills the entire femur and tibia with a combination of exposure and speed mode.They used the suction and irrigation tubing as his technique permits and there is still significant bone debris.There is additional suction used on the field as well as much as possible.No other complications were reported.

Manufacturer Narrative

H3, h6: the product, ri robotic drill, rob10013, used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may be associated with improper assembly of tubing resulting in inadequate irrigation and suction, failure to clear surfaces of residual debris using irrigation, suction and/or hand tool orientation with respect to bone surface, limiting debris.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 11329739
• MDR Text Key: 232321621
• Report Number: 3010266064-2021-00111
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 00885556757321
• Combination Product (y/n): N
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10013
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1