• 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, PRODUCT CODE: OLO

  • 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, PRODUCT CODE: OLO Back to Search Results
Model Number NPFS02000
Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Joint Swelling (2356); No Code Available (3191)
Event Date 10/20/2017
Event Type  Injury  
Manufacturer Narrative
Investigation narrative: the surgical questionnaire on the adverse event form noted that the issue was "possibly" related to the navio or the implant but also noted that it was "possibly" unrelated to the study. The navio¿ surgical system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, and assists in preparation of bone cuts, based on prosthesis plan, taking into consideration 3d bone anatomy and ligament structures. Evaluation of the system archive and screenshots of the patient's procedure indicates that the planned locations of the implant, the predicted gap/ligament balancing and leg alignment are consistent with the post op results. Therefore the navio system performed as expected (i. E. The planned outcome aligns with the achieved outcome). Furthermore, the patient's relevant medical history shows a previous left hamstring tear which is the same hamstring that was irritated and ultimately caused the decision to perform a tka revision.
 
Event Description
It was reported that the patient experienced hamstring irritation and ischial tuberosity bursitis that resulted in revision surgery to a total knee arthroplasty.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNAVIO
Type of DeviceSTEROTAXIC INSTRUMENT, COMPUTER ASSISTED, PRODUCT CODE: OLO
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
mn, PA 15222
4126833844
MDR Report Key7080653
MDR Text Key115958402
Report Number3010266064-2017-00018
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup,Followup,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNPFS02000
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2020
Was Device Evaluated by Manufacturer? Yes
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: 12/04/2017 Patient Sequence Number: 1
-
-