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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Event Description
It was reported that, before a navio procedure, the handpiece could not complete handpiece diagnostic test (torque value of 98, iterations 0/10).Upon inspection, it was noticed that the snaplock inside the handpiece had broken.They swapped it for its back up from another tray and were able to start the case without delays or issues.No other complications were reported.
 
Manufacturer Narrative
The navio, handpiece, part number 110137 sn: (b)(6) intended for treatment was returned for evaluation.The reported problem was visually confirmed.The black snap lock nut is broken.Although the reported problem was visually confirmed, a functional evaluation could not be performed due to the broken snap lock nut.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 has identified prior events.The most likely cause of this event is a mechanical component failure of the snap lock nut.As a part of corrective action, a more robust design of the snap lock has been released.
 
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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 55441
MDR Report Key10701908
MDR Text Key212076468
Report Number3010266064-2020-01898
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556628515
UDI-Public00885556628515
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,health
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Date Manufacturer Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NAVIO SURGICAL SYSTEM US
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