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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR120010
Device Problem Defective Component (2292)
Patient Problem Injury (2348)
Event Date 02/03/2017
Event Type  malfunction  
Event Description
During femur cutting, surgeon commented that he thought he was cutting way too much from the posterior femur; however, the bone model did not turn red. Prior to entering cutting, the femur checkpoint passed, so we were not concerned about the femur tracker's rigidity. Just after he commented about the depth, we switched to speed control and went back to planning to double check our posterior femur cut depth. The cut seemed well aligned with the mesh. When the scrub tech handed dr. Carangelo the handpiece, the tracker came off.
 
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Brand NameNAVIO HANDPIECE TRACKER ARRAY
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9993928
MDR Text Key188841234
Report Number3010266064-2020-00531
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR120010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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