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

Catalog Number ROB10013

Device Problem Connection Problem (2900)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported that, during set-up for a cori assisted tka, a real intelligence robotic drill had a communication error and displayed "put in contact with customer support robotics".The procedure was resumed, after a non-significant delay, by changing to a manual procedure.Since the issue was noticed before procedure, patient was not yet involved.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

Section h10: the real intelligence robotic cori drill (b)(4), (b)(6), used during treatment, was returned for evaluation.Nothing was visually identified that leads to the reported scenario.A functional evaluation was performed, and the reported scenario cannot be confirmed.A key performance characteristics (kpc) test and a test case were performed and were completed without showing the ¿communication error¿ mentioned in the reported complaint, or any additional errors.The drill was opened for further investigation.The exposure motor was tested and passed.The thermistor was tested and passed.The drill was disassembled but no defects were found.The drill was reassembled, and a test case was performed again.Again, no failures occurred.The drill is functioning as intended.An engineering review was completed.The exposure motor was tested and found to be responsive.Although the reported problem could not be confirmed through a visual or functional evaluation, factors that may have contributed to the reported symptom may have been associated an intermittent connection between the drill and the console.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).

• 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
• 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: 18642017
• MDR Text Key: 334566077
• Report Number: 3010266064-2024-00018
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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: PN: ROB10024, LOT: SN000277