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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 110137
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem No Patient Involvement (2645)
Event Date 05/03/2018
Event Type  malfunction  
Event Description
It was reported a system error while in the distal bur of a journey xr sawbone demo.After system kicked out received the warning that internal cabling/ drill console error.Required the system to shut down and when rebooting, black screen showed a message about contacting customer service and could not use the system.Case was aborted.
 
Manufacturer Narrative
H10 h3, h6: the device, intended for use in treatment was returned for investigation.The initial functional evaluation of the handpiece found that there was a short in the cabling.The device history record (dhr) was reviewed and the device met manufacturing specifications prior to being released for distribution.A complaint history review found similar complaints of the reported issue and will continue to be monitored.The short in the handpiece cabling caused the blown fuse in the siu.The relationship of the device and the reported event has been established.The blown fuse was due to a short in the handpiece cabling.The root cause of the reported event was due to an electrical component failure.
 
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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 Key9993906
MDR Text Key188853987
Report Number3010266064-2020-00803
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 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110137
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PART NUMBER 220025; SIU - 220025; PART NUMBER 220025
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