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

Catalog Number PFSR110137

Device Problems Misassembled (1398); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2018

Event Type  malfunction  

Event Description

It was reported that the handpiece seems unable to move the drill in and out as it should.The problem has been traced to the black rubber part, which has gotten loose and is interfering with the calibration.Some of the rubber may have also been caught into the moving mechanisms.The snap lock nut has broken loose.As noticed during in-service, no case was involved.

Manufacturer Narrative

The navio handpiece intended for use in treatment, had a broken snap lock nut and a loose black rubber hard stop prior to a procedure on 23-aug-2018.There was no impact on the case.The device was not being used on a patient during the reported event and no injuries were reported.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.Service record (sr# 210614) is not available and the part was scrapped.A visual and functional investigation could not be performed.The root cause of this issue is undetermined.

• 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: 9993976
• MDR Text Key: 190010110
• Report Number: 3010266064-2020-00728
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1