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

Model Number PFSR110137

Device Problem Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

It was reported that before surgery after inserting the anspach drill with the long attachment into the handpiece snaplock, the drill was stuck and the snaplock assembly came away with the drill after trying to remove the drill from the handpiece.The rep informed the customer did not follow the correct sterilization process.Less than 30 minutes delay was reported and a backup device was available.No injury to the patient.

Manufacturer Narrative

The navio handpiece, intended for use in treatment, was returned for further evaluation and a visual and functional inspection was performed, which confirmed the reported event.Visual inspection confirmed the broken snap lock.The snap lock was completely broken and missing the lead in, plungers, plunger holder, and wave spring.Functional evaluation found that because of all the missing pieces on the snap lock, it will not hold or engage a drill.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 and this issue will continue to be monitored.The root cause was found to be mechanical component failure.As part of corrective actions, a new and more robust design of the snap lock has been released.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999191
• MDR Text Key: 188937737
• Report Number: 3010266064-2020-01366
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: ORPFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1