TFN-ADVANCE 04.038.415SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982099358), received between Aug 12, 2021 and Jul 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE OPERATION, IT WAS NOTED THAT THE TWO REFERENCES PROVIDED BY THE PHARMACIST WERE NOT UTILIZED, AS THE BLADE DID NOT FIT THE NAIL. CONSEQUENTLY, A REQUEST WAS MADE TO REPLACE THESE TWO REFERENCES WITH NEW ONES FOR THE CONSIGNMENT SET. THE HOSPITAL PROMPTLY ORDERED THE TWO NEW REFERENCES DUE TO THEIR FREQUENT USE. IT WAS NECESSARY TO USE AN ALTERNATIVE BLADE AND NAIL DURING THE OPERATION BECAUSE OF THIS ISSUE, THE PROCEDURE WAS PROLONGED BY SEVERAL MINUTES. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609719 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE HAS BEEN A SURGICAL SITE INFECTION AT THE HOSPITAL INVOLVING DEPUY SYNTHES DEVICES THAT WERE INVOLVED IN A HIP NAILING WITH NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20371000 ↗
• MalfunctionAug 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, TFNA FENESTRATED HELICAL BLADE, TI CANNULATED TFNA NAIL, AND AN UNKNOWN SCREW WERE RECEIVED BROKEN. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENTS ARE REPORTED. THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 115MM - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316133 ↗

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