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

Model Number PFSR110006

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

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.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 further containment or corrective actions are recommended at this time.

Event Description

It was reported that during preventive maintenance, the long attachment jams in the handpiece after trying to unlock the anspach drill.The long attachment also feels rough when inserting into the handpiece.No case 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.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(s) "jamming / seizing" 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: 10311584
• MDR Text Key: 199987076
• Report Number: 3010266064-2020-01678
• 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
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1