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

Model Number PFSR110006

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2019

Event Type  malfunction  

Event Description

It was reported that during machine setup for surgery it was found that the long attachment is not fitting properly on the drill due to one ball bearing came out of the long attachment.No patient involved.

Manufacturer Narrative

The device used for treatment was returned.The exterior condition shows minor wear (scratches).Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The long attachment was attached to a drill and bur was attempted to be inserted into long attachment.The reported complaint was confirmed.The bearing is obstructing the bur from passing through.A review of manufacturing records found no related non-conformances or anomalies associated with this device during production.Therefore the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the long attachment and failure mode identified similar events.The most likely cause of this event is internal bearing deterioration/breakdown of bearings and it's components due to excessive heat during use and or water ingress during sterilization processing.Navio surgical system instrument kit cleaning and sterilization guide 500094 rev g indicates to "refer to the anspach emax 2 plus system user¿s manual for instructions on mechanical/automated cleaning of the anspach emax 2 plus surgical drill and long attachment." no containment or corrective actions are recommended at this time.

Manufacturer Narrative

Results of investigation have been corrected as follows: the device used for treatment was returned.The exterior condition shows minor wear (scratches).Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The long attachment was attached to a drill and bur was attempted to be inserted into long attachment.The reported complaint was confirmed.The bearing is obstructing the bur from passing through.A review of manufacturing records found no related non-conformances or anomalies associated with this device during production.Therefore the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the long attachment and failure mode identified similar events.The most likely cause of this event is internal bearing deterioration/breakdown of bearings and it's components due to excessive heat during use and or water ingress during sterilization processing.This issue is being further investigated under corrective action.

• 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: 9992765
• MDR Text Key: 188733175
• Report Number: 3010266064-2020-01264
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2020

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: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2019
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 07/20/2020
• Supplement Dates FDA Received: 07/21/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1