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

Catalog Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2017

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the handpiece would not home correctly, the gears were jammed.The gears were adjusted in different positions but the burr would only move backward and not forward to touch metal plate.A new handpiece was used in order to start with the case.No surgical delay or patient injury was reported.Results of the investigation have concluded that the internal components of the handpiece motor have issues, causing increased torque values, which makes it a reportable event.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.The initial functional inspection of the returned device found that the internal components of the handpiece motor had begun to deteriorate/fail, causing the increased torque values and the subsequent homing failures.The device history record was reviewed finding that the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar complaints of the reported issues.The relationship of the device and the reported event has been established.The handpiece likely had internal motor issues which caused the reported event.Therefore, the root cause of the reported event was due to raw material/supplier fault.

• 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: 9993712
• MDR Text Key: 188857803
• Report Number: 3010266064-2020-00482
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1