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

Catalog Number ROB10013

Device Problem Overheating of Device (1437)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during cori assisted ukr surgery, while milling the femur, the real intelligence robotic drill started to overheat.Surgeon was able to finish the femur preparation, but then for the tibia preparation, it was decided to continue by manual procedure.Surgery was not delayed as consequence of the problem.No injuries to the patient were reported.

Manufacturer Narrative

Section h10: the real intelligence robotic cori drill rob10013, sn(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 can be confirmed.A key performance characteristics (kpc) test was performed during which the burr did not spin, but the motor was heard spinning.The drill was opened for further investigation.The exposure motor was tested and passed.The motors were removed, and it was noticed that the slip shaft had broken in two.One part of the slip shaft was stuck inside the carriage.The carriage was disassembled.It was noticed that the carriage was full of debris and was corroded.The top bearing was broken.The piece of the slip shaft was removed, it was melted and deformed.The defective parts were replaced.A kpc test and a test case where performed, both passed.An engineering review was completed.The exposure motor was tested and found to be responsive.The most likely cause for the reported scenario is a disintegrated bearing and a broken slip shaft.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: 18608862
• MDR Text Key: 334734144
• Report Number: 3010266064-2024-00014
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757321
• UDI-Public: 885556757321
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/05/2024

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 Catalogue Number: ROB10013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/05/2024
• 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: A
• Patient Sequence Number: 1
• Treatment: REAL INTELLIGENCE CORI, PN: ROB10024, SN (B)(6)