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

Model Number PFSR110006

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported that, before a navio tka procedure, the internal metal wiring inside the long attachment had come loose and is blocking the pathway for the bur to insert properly.It was swapped for its back-up to proceed without delays.No other complications were reported.

Manufacturer Narrative

The navio long attachment intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed the long attachment performance verification.The reported problem was confirmed.The internal bearings are disintegrated causing an obstruction in the long attachment.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the part with the failure modes "break | unintended movement" and "damaged or broken component", "jamming / seizing blockage" identified similar events.The most likely cause of this event is degradation/collapse of the long attachment internal bearings making insertion difficult or not possible.Further investigation into the reported failure is being conducted to determine if additional actions are required.Our reference number: (b)(4).

• Brand Name: NAVIO LONG ATTACHMENT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10718353
• MDR Text Key: 212501905
• Report Number: 3010266064-2020-01937
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1