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

Model Number ROB10016

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a cori assisted tka surgery, they noticed that the connection for the bur guard became detached from the real intelligence robotic drill guard.It was connected to the suction tubing and the bur guard was attached to the robotic drill attachment.Both pieces were removed from the field.It is unknown how the procedure was completed.No delays reported.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

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 barbed suction tube was completely detached.An outline consisting of weld material remains on the surface of the guard.There is no weld material remaining in the area just below the barb.A functional evaluation could not be performed due to the nature of the broken weld.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.The most likely cause of the reported problem is an incomplete weld around the perimeter of the irrigation tube.As part of our continued process improvement a review of prior escalation actions has determined that this case and associated lot/serial number is related to a corrective/preventive action, nonetheless, no containment has been required.The real intelligence cori for knee arthroplasty user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d".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 burring during a cori assisted tka surgery, they noticed that the connection for the bur guard became detached from the real intelligence robotic drill guard.It was connected to the suction tubing and the bur guard was attached to the robotic drill attachment.No pieces fell inside the patient and both pieces were removed from the field.It is unknown how the procedure was completed.No delays reported.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: 12870374
• MDR Text Key: 281284733
• Report Number: 3010266064-2021-00807
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: (10)1345065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 02/21/2022; 02/21/2022
• Supplement Dates FDA Received: 02/24/2022; 12/07/2022
• 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: A
• Patient Sequence Number: 1