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

Catalog Number 110004

Device Problem Defective Component (2292)

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

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported that during a surgical procedure, the system experienced a homing failure.Necessary troubleshooting was performed, and the handpiece needed to be replaced to continue with the case.No surgical delay or patient injury was reported.Results of investigation have concluded that the drill guide support on the handpiece was bent, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece, used in treatment, was returned for further evaluation and the initial visual confirmed the reported event.The screenshots from the case are consistent with a drill that was unsnapped from the handpiece.The affected handpiece is on a list of handpieces that have a known potentially bad snap lock.The root cause of this issue was found to be due to supplier / raw material fault.A device history record review found the device met all specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The naviopfs system for unicondylar knee replacement (ukr) user's manual contains no information regarding the broken snap lock which led to the drill unsnapping from the handpiece.This failure is also captured in the navio risk profile.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9996835
• MDR Text Key: 188868946
• Report Number: 3010266064-2020-00195
• 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: 08/07/2020

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR