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

Catalog Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Event Description

It was reported during a surgical procedure, the exposure guard would not securely fit and lock into the handpiece.After forcing it to lock, it was then jammed when trying to remove it.After the case, the customer tried to get the guard to lock in and could not either.This caused a brief delay in the surgery while the surgeon tried to switch the exposure guard out for the visualization/plate guard.It seems as the barrel/tip may be bent as each guard we tried did not slide on easily.

Manufacturer Narrative

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: 9988807
• MDR Text Key: 188674114
• Report Number: 3010266064-2020-00635
• 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

• 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
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR