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

Model Number PFSR110137

Device Problems Defective Device (2588); Mechanical Jam (2983)

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

Event Date 10/21/2020

Event Type  malfunction  

Event Description

It was reported that when spd was cleaning the hand piece, they stated the gears would not turn.They lubed them, and manually tried to get them to turn without any luck.Not during surgery.No delay.No patient harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.The gear would not turn by hand.A handpiece test was then performed.The gears were able to turn by hand after the test.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 probable cause of the reported problem is early stage motor failure.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: 10819776
• MDR Text Key: 216204266
• Report Number: 3010266064-2020-01987
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: K170360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• 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
• Treatment: NPFS02000