TFN-ADVANCE 04.038.180Recalls & reported problems
Synthes GmbH · TFNA FENESTRATED SCREW 80MM · 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 10886982098689), received between Apr 24, 2023 and Apr 24, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A TFNA IN (B)(6) 2022. THE NAIL WAS REMOVED ON (B)(6) 2023 DUE TO A PERIPROSTHETIC FRACTURE OCCURRING DISTAL TO THE SHORT TFNA. THE FRACTURE WAS NOTICED ALONG THE SHAFT OF THE NAIL. THE SURGEON SUSPECTS THAT THE FRACTURE WAS THERE BEFORE THE NAIL WAS PLACED. DURING THE PROCEDURE, THE RUBBER TIPS ON THE REAMING ROD WERE HARD TO REMOVE, HOWEVER THEY WERE REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 80MM. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 16797908 ↗
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-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
- 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
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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