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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2020
Event Type  Injury  
Event Description
It was reported that during a tka procedure, after completing the distal femur cut accurately, they placed the 5-in-1 cutting block on the femur and checked the anterior slot with the plane checker. It was 4 mm anteriorized to the plan on the screen. The surgeon posteriorized the block 2 mm (which required two additional bone holes to be made) and then rechecked the anterior slot, which read 0. 9 mm anteriorized to the plan. Proceeded with the saw cuts and was satisfied with the final result. To troubleshoot, we checked the checkpoints and they passed, the handpiece array was verified secured, and when navigated the probe to the pilot holes, they were within the bounds. There was a delay of less than 30 minutes. No other complications were reported.
 
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Brand NameNAVIO SURGICAL SYSTEM US
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
4126833844
MDR Report Key10228423
MDR Text Key197542719
Report Number3010266064-2020-01629
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
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: 07/03/2020 Patient Sequence Number: 1
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