• 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 SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • 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 SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT 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 Wound Dehiscence (1154); Bone Fracture(s) (1870)
Event Date 07/24/2017
Event Type  Injury  
Manufacturer Narrative
Investigation narrative: based on the x-rays, we are unable to see the exact location of the navio bone screws. The surgeon believed that the line of fracture was through the navio bone screw locations. It is impossible to determine definitively if the bone screw placement did or did not cause the femur fracture, however drilling bone screws through the bone would obviously weaken the bone (expected behavior) and that combined with a fall could cause a fracture. The path through the two screws would be the most likely place for the fracture line as it is the weakest portion of the bone so close to the date of surgery. As of the date of this event, there had only been one other reported instance of bone fracture with navio bone screw use and it was a tibia and the same surgeon performing the case.
 
Event Description
It was reported that the patient suffered a femur fracture at the pin site. The patient had post-op follow up and showed a displaced supracondylar distal femur fracture and also wound dehiscence that required revision surgery including washing out/poly change/orif of the patient's distal femur. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that the patient suffered a femur fracture at the pin site. She came in post-operatively with a displaced supracondylar distal femur fracture and also dehisced her wound that required revision surgery including washing out/poly change/orif of the patient's distal femur.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest
blvd ste 40
plymouth, mn MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest
blvd ste 40
plymouth, mn MN 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa, PA 15222
4126833844
MDR Report Key6809299
MDR Text Key121626947
Report Number3010266064-2017-00014
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
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNPFS02000
Device Catalogue NumberPFSD101111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/11/2020
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: 08/21/2017 Patient Sequence Number: 1
-
-