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

Model Number PFSR110137

Device Problems Failure to Calibrate (2440); Naturally Worn (2988); Physical Resistance/Sticking (4012)

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

Event Date 04/05/2021

Event Type  malfunction  

Event Description

It was reported that, during set up of a navio ukr procedure, the handpiece failed to calibrate multiple times.They switched pointer probe and tracker array, and eventually switched handpiece.After switching the handpiece, everything calibrated fine.The groves on the handpiece are severely worn (damaged clamshell) and it seems like the pointer probe is not seating properly.Since incident occurred before the procedure, there was no patient involvement.No other complications were reported.

Manufacturer Narrative

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 point probe grooves are very worn.Although the reported problem was visually confirmed, a functional evaluation was performed.The handpiece passed all tests.A review of manufacturing and service 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 wear and tear of the point probe grooves over time.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• 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: 11728623
• MDR Text Key: 248363745
• Report Number: 3010266064-2021-00301
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 04/20/2021
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1