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

Model Number ROB10016

Device Problem Break (1069)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: case- (b)(4).

Event Description

It was reported that, while the surgeon was burring the femur in a cori assisted tka surgery, the real intelligence robotic drill guard was spinning around the robotic drill attachment and suddenly broke loose.The surgeon immediately stopped, removed the broken exposure guard, disconnected broken piece from suction tubing, and inspected the patient for any pieces left behind.After confirming all pieces were removed, a second guard was taken from the tray and used to complete the case.The procedure was finished with a smith and nephew back up device with a 1 minute delay.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

Additional information: d4.H3, h6: the real intelligence robotic drill guard, part number rob10016, lot1345065 used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The suction tube is detached from the guard body.A functional evaluation could not be performed due to the nature of the broken weld.The reported problem was confirmed visually.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is an incomplete weld around the perimeter of the irrigation tube.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions determined this case and associated lot or serial number is associated with a capa and no further action is required.Refer to the product user manual which provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that while the surgeon was burring the femur in a cori assisted tka surgery, the real intelligence robotic drill guard was spinning around the robotic drill attachment and suddenly broke loose.The surgeon immediately stopped, removed the broken exposure guard, disconnected broken piece from suction tubing, and inspected the patient for any pieces left behind.After confirming all pieces were removed, a second guard was taken from the tray and used to complete the case.The procedure was finished with a smith & nephew back up device with a 1 minute delay.The patient was not harmed beyond the reported problem.Further investigation into the reported failure and remediation is being conducted to determine if additional actions are required.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

Manufacturer Narrative

The manufacturer has identified that this event should be re-evaluated for mdr reporting.The detached component is of a size/shape that can be easily retrieved in its entirety and this malfunction has been resolved by using an available back-up device.Although this event may result in a short delay while the procedure is resumed and completed as intended, this malfunction has not caused or contributed, in the past, to a death or serious injury, nor has it been required a medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.This malfunction is unlikely to cause any death or serious injury if it were to recur, either.Therefore, this event is considered non-reportable pursuant to 21 c.F.R.§803.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: REAL INTELLIGENCE ROBOTIC DRILL GUARD
• 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: 13114913
• MDR Text Key: 282973549
• Report Number: 3010266064-2021-00923
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757352
• UDI-Public: 00885556757352
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10016
• Device Catalogue Number: ROB10016
• Device Lot Number: 1345065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS USA / ROB20000.
• Patient Outcome(s): Required Intervention