• 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 HANDPIECE 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 HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110137
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
The device used for treatment was returned for evaluation. Nothing was identified visually that contributed to the reported problem. Functional evaluation was performed and the reported problem was confirmed. The initial handpiece characterization test failed. The handpiece characterization test evaluates the amount of torque needed for proper motor function. The handpiece was then sterilized and the handpiece characterization test was re-performed twice more, where the t1 torque failed at 48 and the subsequent test was 12. These results after sterilization indicate signs of motor failure. A review of manufacturing and service records indicate the device met all specifications upon release into distribution. A complaint history review for similar reported/confirmed complaints associated with the handpiece and failure mode(s) "jamming / seizing" identified similar events. The most likely cause of this event is the mechanical failure of the motor. Further investigation into the reported failure is being conducted to determine if additional actions are required.
 
Event Description
It was reported that during the case, they could not get the handpiece to home after multiple troubleshooting attempts. They swapped the handpiece out and were able to get the replacement handpiece to work. At end of the case, they ran a handpiece test and max torque number came back at 66. There was a delay of fewer than 30 minutes and no patient impact was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO HANDPIECE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
Manufacturer Contact
rick confer
2828 liberty ave
suite 100
pittsburgh, PA 38116
4126833844
MDR Report Key10708479
MDR Text Key212503005
Report Number3010266064-2020-01903
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556628515
UDI-Public00885556628515
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
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

-
-