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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE Back to Search Results
Model Number PFSR110137
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
It was reported that during a navio assisted tka surgery halfway through burring entire femur the navio handpiece had a "handpiece exposure control motor failure" disconnect error.They proceeded to hit dismiss, recalibrated and continued case with no further delay.The procedure was completed with a delay (fewer than 3 minutes) and the same device.No patient injuries and no other complications were reported.
 
Manufacturer Narrative
The navio handpiece part number 110137, sn (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device was confirmed.Nothing was identified visually that contributed to the reported problem.The reported problem was confirmed.The handpiece produced a communication error during the test when flexing the cable at the handpiece end.A review of manufacturing 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 failure of the wiring connection.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
NAVIO HANDPIECE
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key11921231
MDR Text Key253784799
Report Number3010266064-2021-00434
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 health professional
Type of Report Initial,Followup
Report Date 08/04/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/21/2021
Initial Date FDA Received06/02/2021
Supplement Dates Manufacturer Received08/04/2021
Supplement Dates FDA Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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