MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

It was reported that during a demonstration, the handpiece and drill were difficult to assembly.Both were stuck.Results of investigation have concluded that the drill guide support on the handpiece was bent, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the device, intended for use in treatment, was returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports.The initial visual/functional investigation found that: the drill was removed from the handpiece; however, it was noticed that the drill guide support was bent sideways.This caused the drill and long attachment to be installed at an angle and not concentric with the snap lock assembly.The angle caused the difficulty in installing and removing the drill.A relationship between the device and the reported event could be established.The malfunction is likely due to mechanical component failure from bending of the handpiece drill guide support.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9988786
• MDR Text Key: 188672023
• Report Number: 3010266064-2020-00618
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1