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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR110137
Device Problem Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Event Description
It was reported that the handpiece and point probe would not calibrate.These parts were reassembled multiples times.The case has to be aborted and use manual instruments because there was no backup available.
 
Manufacturer Narrative
H10: h3, h6: the navio handpiece, intended for use in treatment, was not return for evaluation.The device had repeated calibration failures prior to a procedure.A device history record review found no conditions which could contribute to the reported event and the device met all specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system for unicondylar knee replacement and patellofemoral arthroplasty user's manual released at the time of the complaint provides instructions on calibration issues.This failure is captured in the navio risk profile.The navio handpiece was not returned for further evaluation and an initial visual/functional investigation was not performed.However, the log files indicate a z-error on every attempt.This error is related to the vertical distance between the handpiece tracker and the point probe.The tracker, handpiece (dowel pin) or point probe could be the cause of the error.The root cause of this issue was found to be undetermined.
 
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Brand Name
HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9994366
MDR Text Key188815251
Report Number3010266064-2020-00441
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,health
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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