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

Model Number PFSR110006

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported that, after a navio tka procedure, the long attachment was stuck inside the handpiece.They made several attempts to separate the two pieces, and were able to do so, but the long attachment had broken into two pieces when finally disassembled from the handpiece.No patient was involved.

Manufacturer Narrative

The navio long attachment, part number 110006 used in treatment was returned for evaluation.The reported problem was visually confirmed.The attachment is in two pieces.The two pins that hold the nozzle in place have been sheared off due to excessive force with an unknown tool removing the distal end from the base of the long attachment.A functional evaluation could not be performed due to broken/damaged parts.Review of manufacturing records found no related non-conformances or anomalies associated with this part number during production.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 galling (heat/friction cause long attachment/drill located in the handpiece snap lock to adhere to the snap lock) between the handpiece snap lock and long attachment and drill leading the user to apply excessive force to separate the long attachment/drill from the hp.Galling occurs because hp snap lock was not lubricated prior to sterilization.Navio surgical system instrument kit cleaning and sterilization guide indicates to "refer to the anspach emax 2 plus system user¿s manual for instructions on mechanical/automated cleaning and lubrication of the anspach emax 2 plus surgical drill and long attachment".No containment or corrective actions are recommended at this time.

• 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: 10718085
• MDR Text Key: 212495217
• Report Number: 3010266064-2020-01936
• 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: 05/28/2021

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?: Yes
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1