MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10015

Device Problem Overheating of Device (1437)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The cori drill attachment intended for use in treatment was returned.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A kpc test was run and the test passed.The reported problem was confirmed.The drill attachment was hot to the touch during and after testing.The drill attachment shaft was opened and it was found that there was debris on the lower bearing.The debris was removed and the test was run again without any issues.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 associated with the part with the failure modes 'material deformation' identified similar events.The most likely cause of this event was debris behind the wiper in the long attachment shaft causing resistance with the bur.Based on the investigation, no further containment or corrective action is recommended or required at this time.Internal complaint reference number: (b)(4).

Event Description

It was reported that during cori tka procedure, while the patient was under anesthesia, after calibrating the handpiece, they ran the test spin.They passed calibration, but could not pass divot check.They exited out of case, re-entered case, failed to pass divot check.Tried again, created a new case, but still failed.Powered down the system, created new case, failed.Tried other divot, failed.They used another drill attachment again and passed and were able to complete the procedure with a delay of fewer than 30 minutes.The investigation found that the drill attachment was hot to the touch and was found with debris on the lower bearing.

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 11579327
• MDR Text Key: 242626843
• Report Number: 3010266064-2021-00227
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• 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: Reuse
• Patient Sequence Number: 1