• 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 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; 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 HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 110137
Device Problem Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2018
Event Type  malfunction  
Event Description
It was reported tha the handpiece did not complete the calibration: when doing the test of the handpiece, it is observed that the black rubber is loose.This was noticed in a demo; therefore, no patient was involved.The results of investigation indicate that the snaplock nut was broken, which is a reportable malfunction.
 
Manufacturer Narrative
H10: the navio handpiece (part number 110137 / serial number (b)(6) intended for use in treatment, could not complete calibration and had a loose black rubber on (b)(6) 2018.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The snap lock nut was broken.However, this does not affect calibration.The reporter likely meant that the handpiece did not complete retraction or homing.The root cause of this issue was found to be mechanical component failure.As part of corrective actions, a new and more robust design of the snaplock has been released.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9995842
MDR Text Key188858773
Report Number3010266064-2020-00764
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/04/2020
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 No Information
Device Catalogue Number110137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received04/24/2020
Supplement Dates Manufacturer Received07/28/2020
Supplement Dates FDA Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-