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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 Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  Injury  
Event Description
It was reported that, during set up for a case, the handpiece did not calibrate forcing an error to pop up.The system was rebooted per error and then integrity test error 40000000000 came up.Navio was aborted and case was completed with manual instruments.The patient outcome is unknown.The result of investigation indicate that the damaged cord caused a short circuit that blew a fuse in the siu, which is a reportable malfunction.
 
Manufacturer Narrative
H10: h3, h6.The device, intended for use in treatment, was returned for investigation.The initial evaluation of the handpiece found that there was short in the cabling.The dhr was reviewed and the product met manufacturing specifications.A complaint history review found similar complaints of the reported issues and will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions on how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A failure can consist of, but is not limited, a system software crash, unrecoverable hardware failure, handpiece failure with no back available, tracker array failure or loss of contact with bone that is unrecoverable, etc.Since the issue was due to component failure, product labeling has been ruled out as a cause of the complaint.This failure is an identified failure mode within the risk file.The relationship of the device and the reported event has been established.The short in the handpiece cabling caused the blown fuse in the siu.The root cause of the reported event was due to 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 Key9994102
MDR Text Key189345434
Report Number3010266064-2020-00756
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 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110137
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received04/23/2020
Supplement Dates Manufacturer Received08/11/2020
Supplement Dates FDA Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SIU - 220025
Patient Outcome(s) Required Intervention;
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