EF1Recalls & reported problems across all models
Medshape, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one EF1 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 4 models of EF1 by Medshape, Inc. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2025 and Dec 16, 2025 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EF1 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 2, 2025Class IIOpen, Classified
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Z-2513-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported EF1 problems
Device problems
- Material Integrity Problem5
- Adverse Event Without Identified Device or Use Problem4
- Detachment of Device or Device Component4
- Mechanical Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
EF1 models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EF1 DNE-9000-UJAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall3 reports
- EF1 DNE-6000-201Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component3 reports
- EF1 DNE-6000-200Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2 reports
- EF1 DNE-6000-036Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 report
Recent EF1 adverse event reports
The 9 most recent reports across all models, 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 23824374 ↗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 ↗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 23824365 ↗MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DEVICE BROKE POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931589 ↗MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
COMPLAINT: DEVICE BROKE POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931581 ↗MalfunctionApr 29, 2025Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DEVICE BROKE POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21931579 ↗InjuryMar 11, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POST-OP X-RAY SHOWED A BROKEN 5MM HALF PIN IN THE TIBIA. DOCTOR EXPLAINED THAT THE MOST PROXIMAL HALF PIN HAD BECOME DETACHED FROM THE FRAME AND THE PATIENT HAD SUBSEQUENTLY BROKEN THE MOST DISTAL TIBIAL HALF PIN. ALSO, SOME OF THE NUTS WERE ROUNDED AND CROSS THREADED. HE COMMENTED THAT THE METAL WAS TOO SOFT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 21579854 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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