MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO 9BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 110137

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

It was reported that during a tka and pfa procedures, the center cannula and the long attachment slides through to lock into the handpiece appeared tight and might be slightly warped.Unable to use it for 2 cases and instead had to pull a different tray in each case.This is for the second case.

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 reports.Functional inspection was performed by inserting the long attachment backwards into the handpiece and could not be inserted, indicative of a bent drill guide support.This is reasonable because the drill guide support on the handpiece is aluminum.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: HANDPIECE, NAVIO 9BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9995843
• MDR Text Key: 188843319
• Report Number: 3010266064-2020-00772
• 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
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

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: 110137
• 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