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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number PFSR110137
Device Problem Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Date 07/09/2019
Event Type  malfunction  
Event Description
It was reported that during setup for a tka while attempting to complete admin hand piece test the navio produced an error stating "cannot communicate with hand piece please be sure all cables are connected. " sales rep attempted to run the hand piece test again and the same error was reported. Following the second error message the hand piece and anspach drill were unplugged and the test was attempted again with no success. The navio was then shut down rebooted. While the navio was rebooting the hand piece and anspach drill connector pins were checked and did not show signs of damage. Handpiece serial number (b)(4) was removed and a new navio tray was opened. The hand piece from the new tray was assembled and tested with no errors reported. Following the days cases sales rep tested hand piece (b)(4) on the navio at the phoenix lab and received no error messages. No patient involved. Investigation results determined that a connectivity issue at the handpiece end of the cable, the internal wiring at that end had come apart in the cable causing a short in the wiring, which is a reportable event.
 
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Brand NameNAVIO HANDPIECE
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
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
7634524980
MDR Report Key9998954
MDR Text Key189335452
Report Number3010266064-2020-01341
Device Sequence Number1
Product Code OLO
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,Followup
Report Date 08/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPFSR110137
Device Catalogue NumberORPFSR110137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2019
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

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