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 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that while burring the uni femur during a cori assisted ukr surgery, the suction arm snapped off.No debris entered the surgical site or field.Suction arm and bur guard were retrieved.The procedure was completed, without delay, using a s+n back up device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6; the real intelligence robotic drill guard part number rob10016, lot number 101341426, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the real intelligence cori for knee arthroplasty user manual (500230 rev d) page 29, section ¿setting up a cori knee procedure¿, ¿preparing the suction tubing¿ for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an incomplete weld to secure the suction tube to the guard body.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.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: 13615155
• MDR Text Key: 286744354
• Report Number: 3010266064-2022-00137
• 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: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2022
• 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: 101341426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• 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: ROB20000-CORI ROBOTICS USA
• Patient Outcome(s): Other