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

Catalog Number ROB10013

Device Problems Overheating of Device (1437); Connection Problem (2900)

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

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

It was reported that during cori assisted ukr surgery, at the time of bone removal, after a few seconds of operation the burr started to work intermittently and the real intelligence robotic drill started to overheat and there was a burning smell.After that, the handpiece disconnected message appeared.Surgery was finished manually without any delay.Patient was not harmed as consequence of the problem.

Manufacturer Narrative

The cori drill rob10013, (b)(6), used in treatment, was returned for evaluation.Nothing was visually identified that contributes to the reported scenario.A functional evaluation was completed.The reported problem that the burr works intermittently, and the drill overheats could be confirmed.A kpc test was performed, during the random exposure (when pressing the foot pedal) the drill worked intermittently.Shortly after that, the drill got extremely hot, and a slight burning smell was noticed.When performing a test case, the burr worked intermittently and was hot.The handpiece disconnect message appeared when letting the test case run.The drill was opened for further investigation.When the main motor was removed, small parts of the bearing fell out.The ball bearing is bearing is broken.Furthermore, the drill motor shaft is burnt and melting.When disassembling the carriage, the remainder of the bearing fell out.The big spacer was stuck inside the carriage and was able to be removed.After replacing the collet (bearings and shaft) no further failures occurred when performing a kpc test and test case.The most likely cause of the reported complaint is due to a disintegrated bearing and melted slip shaft.Review of manufacturing records found no related non-conformances or anomalies associated with this serial number during production.No service records were identified prior to the complaint date for this device.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 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.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: case (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: 17371681
• MDR Text Key: 319503894
• Report Number: 3010266064-2023-00130
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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: 07/07/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/17/2023
• 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: ROB10024, SN: (B)(6)