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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 Defective Component (2292)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Event Description
It was reported that, during navio lab/demo, the drill and long attachment fused into snap lock, every time the long attachment seats into the snap lock it will not release even without any burring.It was tested on another handpiece and was fine.
 
Manufacturer Narrative
The navio handpiece, part number pfsr110137, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.The hp passed handpiece testing and calibration/homing with no incident.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.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of seating drill into handpiece.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
 
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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 Key10701950
MDR Text Key212076176
Report Number3010266064-2020-01899
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,foreig
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Device Lot NumberBB001506
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received10/11/2021
Supplement Dates FDA Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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