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 Patient Involvement (2645)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

It was reported that after replacing both the camera and the cori console, cori sawbone lab/demo was planned and the long attachments were checked respectively with a bur.The bur was inserted in the long attachment to see the resistance presented to the bur, and three long attachments presented resistance.The bearings within the attachments could have an excess of epoxy likely creating friction when spinning the bur which can also create heat.This explains why some of the bur attachments are much hotter than others while burring.No patient was involved.No other complications were reported.

Manufacturer Narrative

The 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 performed and the test passed.The reported problem was not confirmed.The drill attachment functioned as expected without any resistance issues.An engineering evaluation was performed.There are no issues.Passed the kpc test with the same values as a normal long attachment.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 has identified prior events.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.Based on the investigation, no further containment or corrective action is recommended or required at this time.Internal complaint reference number: (b)(4).

• 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
• MDR Report Key: 10564584
• MDR Text Key: 207910211
• Report Number: 3010266064-2020-01784
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (y/n): N
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 09/01/2020
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1