Skip to content

TFN-ADVANCE 04.038.370SRecalls & reported problems

Synthes GmbH · TFNA FENESTRATED HELICAL BLADE 70MM - STERILE · 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 10886982099174), received between Jun 27, 2022 and Jun 27, 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

  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 27, 2022Migration; Migration

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, CUT-OUT OF THE BLADE AND NON-UNION WERE CONFIRMED. ON (B)(6) 2022, ALL THE IMPACTED PRODUCTS WERE EXTRACTED, AND A REVISION SURGERY WAS PERFORMED VIA BHA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 70MM - STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 14830789 ↗

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, Classified
    TFNA 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, Classified
    TFNA 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

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page