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 08/06/2018

Event Type  malfunction  

Event Description

It was reported that during an inspection, three handpieces were tested and the max torque was 98 for each test.Also, the gears would not move when performing the testing.No patient involved.Results of the investigation have concluded that the snaplock assembly was broken, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece intended for use in treatment, had high t1 max torque and gears would not move during testing.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The gears on handpiece could be moved by hand.The snap lock was broken.A broken snap lock nut would prevent the snap lock from moving along the lead screw, causing the handpiece to fail handpiece characterization.The root cause of this issue was found to be mechanical component failure.

• 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: 9997187
• MDR Text Key: 188892807
• Report Number: 3010266064-2020-00688
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1