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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 Problems Mechanical Jam (2983); Mechanics Altered (2984)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2020
Event Type  Injury  
Event Description
It was reported that during a tka procedure, the handpiece-thrust did not work anymore.The handpiece does not move forward and backwards.The small wheel seems to be the fault after visual inspection.It was swapped for its backup to continue with the procedure with a delay of less than 30 minutes.No other complications were reported.
 
Manufacturer Narrative
H3, h6: the navio handpiece pfsr 110137, sn(b)(6), used for treatment was returned for evaluation.The reported issue could not be confirmed.Nothing was identified visually that contributed to the reported problem.Functional evaluation found that the device passed all tests and functioned as expected.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.There were no indications of an issue that would potentially lead to a future performance issue.A complaint history review found similar reports, this issue will continue to be monitored.No problem found with the device.It was reported that the device thrust stopped working during a case.It is possible that there was debris caught in the device, causing a jam, which was cleared when the handpiece was sterilized.No further containment or corrective actions are recommended at this time.
 
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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 Key10203875
MDR Text Key196930288
Report Number3010266064-2020-01614
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Date Manufacturer Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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