TFN-ADVANCE 04.038.375Recalls & reported problems
Synthes GmbH · TFNA FENESTRATED HELICAL BLADE 75MM · Class 2 · Implant
All models of TFN-ADVANCE (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982099181), received between Apr 26, 2022 and Apr 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K160167); they may or may not involve this specific model.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2022Migration; Migration
IT WAS REPORTED THAT ON (B)(6) 2022 AN UNKNOWN HARDWARE WILL BE REMOVED FROM A HIP AND WILL BE CONVERTED TO A TOTAL HIP ARTHROPLASTY. THERE WAS NO ADVERSE EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE TFNA FENESTRATED HELICAL BLADE 75MM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14209206 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160167. One submission often covers many models, so check the product and lot details in each record.
- Z-1239-2024 · Jan 24, 2024 · Open, ClassifiedTFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
- Z-1240-2024 · Jan 24, 2024 · Open, ClassifiedTFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
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 HAA60-15020Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 recalls0 reports
- DFS HA BONE SCREWS HAA60-11030Biomet 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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