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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
Catalog Number PFSR110137
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 01/18/2018
Event Type  malfunction  
Event Description
It was reported that during a demonstration, the handpiece gears were not working.The handpiece did not pass homing.The device was replaced.No patient involved.
 
Manufacturer Narrative
H3, h6: the device was intended to be used during a lab or demonstration and was returned for evaluation.The initial functional inspection of the returned device found that the internal components of the handpiece motor had begun to deteriorate/fail, causing the increased torque values and the subsequent homing failures.The device history record was reviewed finding that the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar complaints of the reported issues.The relationship of the device and the reported event has been established.The handpiece likely had internal motor issues which caused the reported event.However, the motor is an off-the-shelf device manufactured by a supplier.Therefore, the root cause of the reported event was due to raw material/supplier fault.
 
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Brand Name
NAVIO HANDPIECE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9988789
MDR Text Key188670784
Report Number3010266064-2020-00619
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,foreig
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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