• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO LONG ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 38116
4126833844
MDR Report Key10311584
MDR Text Key199987076
Report Number3010266064-2020-01678
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110006
Device Catalogue NumberPFSR110006
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-