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

Model Number PFSR110137

Device Problems Mechanics Altered (2984); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

It was reported that, during navio preventative maintenance, they got a intermittent reading and null reading, and the handpiece test would end without completing the full motor stepper test.There was no patient involvement.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio handpiece part number 110137, sn (b)(6) intended for treatment was returned for evaluation.A relationship between the reported event and the device was confirmed.The reported problem was visually confirmed.The snap lock nut is broken at the threads.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to the snap lock nut is broken.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of this event is a mechanical failure of the snap lock nut.As a part of corrective action, the old style snap lock is being replaced.

• 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: 11735131
• MDR Text Key: 248363431
• Report Number: 3010266064-2021-00308
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1