TFN-ADVANCE 04.038.375SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982099198), received between Oct 15, 2021 and Aug 5, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUL 23, 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR TROCHANTERIC FRACTURE WITH THE NAIL AND THE BLADE. AFTER THE SURGEON INSERTED THE BLADE AND INJECTED CEMENT, HE WAS ABOUT TO INSERT THE LATERAL LOCKING SCREW WHEN HE NOTICED THAT THE AIMING ARM AND INSERTION HANDLE WERE LOOSE. JUST TO BE SURE, THE SURGEON CHECKED THE BLADE AND FOUND THAT IT HAD NOT PASSED THROUGH THE NAIL. THE SURGEON REMOVED THEM, CHANGED THE NAIL FROM F10MM TO F9MM, AND THE BLADE FROM 75MM TO 80MM, AND INSERTED AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON GAVE THE FOLLOWING COMMENTS ABOUT THE CAUSE: 1) THE DEVICE WAS LOOSE, AND 2) WHEN INSERTING THE GUIDE WIRE TO POSITION THE BLADE, THE SURGEON LIFTED THE REDUCTION TOOL WITH FORCE, WHICH PUT STRESS ON THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719538 ↗
• InjuryOct 15, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, WHILE INSERTING A TFNA NAIL, THE SURGEON PERFORATED THE FEMORAL NECK WITH THE HELICAL BLADE. THE NAIL AND HELICAL BLADE WERE EXTRACTED, AND REINSERTED. THE HELICAL BLADE WAS REPOSITIONED IN THE FEMORAL NECK AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING EXTRACTION, ONE OF THE PRONGS OF THE CONNECTION INTERFACE WAS SLIGHTLY BENT; HOWEVER THE NAIL WAS SUCCESSFULLY RECONNECTED AND INSERTED. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 75 - SILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12639890 ↗

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, Classified
  TFNA 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, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S