• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO STEROTAXIC INSTRUMENT, COMPUTER ASSISTED Back to Search Results
Catalog Number NPFS02000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/19/2019
Event Type  Injury  
Manufacturer Narrative
Investigation narrative: initial review of the case screenshots and x-rays indicate that navio was likely not used to cut the tibia and that a saw was used instead. Navio was used plan the femur and tibia implant and cut the femur. From the x-rays, it appears that the angle of the cut from the saw created a stress riser which led to the fracture. Additional information has been requested from the complainant to confirm the preliminary analysis and the investigation is currently ongoing.
 
Event Description
It was reported that the patient experienced a medial tibial plateau fracture approximately 2 months after robotic unicompartment knee replacement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO
Type of DeviceSTEROTAXIC INSTRUMENT, COMPUTER ASSISTED
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW
2905 northwest blvd.
suite 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 Key8333764
MDR Text Key135992113
Report Number3010266064-2019-00001
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K160537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2019
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 Unkown

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
-
-