EF1 DNE-6000-201Recalls & reported problems
Medshape, Inc. · Wire, 2.0 x 450mm, Olive, Bayonet tip · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810028396036), received between Dec 16, 2025 and Dec 16, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THIS CASE THE DOCTOR REPORTED THAT HE COULD NOT ADVANCE THE SMOOTH OR OLIVE EF1 WIRES DUE TO THEM BEING EXTREMELY DULL. THIS ADDED AT LEAST AN EXTRA 20 MINUTES TO THE CASE AS THEY NEEDED TO BE FORCED INTO THE BONE EVERY TIME THEY WERE IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824375 ↗MalfunctionDec 16, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THIS CASE THE DOCTOR REPORTED THAT HE COULD NOT ADVANCE THE SMOOTH OR OLIVE EF1 WIRES DUE TO THEM BEING EXTREMELY DULL. THIS ADDED AT LEAST AN EXTRA 20 MINUTES TO THE CASE AS THEY NEEDED TO BE FORCED INTO THE BONE EVERY TIME THEY WERE IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824373 ↗MalfunctionDec 16, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THIS CASE THE DOCTOR REPORTED THAT HE COULD NOT ADVANCE THE SMOOTH OR OLIVE EF1 WIRES DUE TO THEM BEING EXTREMELY DULL. THIS ADDED AT LEAST AN EXTRA 20 MINUTES TO THE CASE AS THEY NEEDED TO BE FORCED INTO THE BONE EVERY TIME THEY WERE IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824372 ↗
Other Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component devices
- PRECICE® Plating System LP4.5-DLF31Nuvasive Specialized Orthopedics, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3 recalls0 reports
- R3 71364451Smith & Nephew, Inc. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT145 reports
- DFS HA BONE SCREWS HAA60-15040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15050Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAB60-12040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-13040Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-18030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-15030Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.