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

Model Number PFSR110137

Device Problem Defective Component (2292)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Event Description

It was reported that, during navio lab/demo, the drill and long attachment fused into snap lock, every time the long attachment seats into the snap lock it will not release even without any burring.It was tested on another handpiece and was fine.

Manufacturer Narrative

The navio handpiece, part number pfsr110137, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The hp passed handpiece testing and calibration/homing with no incident.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.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of seating drill into handpiece.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: 10701950
• MDR Text Key: 212076176
• Report Number: 3010266064-2020-01899
• 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: 10/12/2021

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
• Device Lot Number: BB001506
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1