TFN-ADVANCE 04.038.395Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982099266), received between Mar 27, 2020 and Mar 29, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TFNA HARDWARE WAS REMOVED DUE TO THE IMPLANT FAILING. THE IMPLANT HAD CUT THROUGH AND HAD CREATED AN ULCER ON THE PATIENT¿S LATERAL SIDE. THE IMPLANT WAS INTACT AND NO FRAGMENTS WERE CREATED. THE PATIENT WAS REVISED WITH A TOTAL HIP ARTHROPLASTY (THA). THIS REPORT INVOLVES ONE (1) TFNA HELICAL BLADE 95MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Ulcer

  MAUDE report 13940047 ↗
• InjuryApr 15, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCED FROM THE PATIENT'S RIGHT HIP. BASED ON XRAYS IT WAS DETERMINED THE HELICAL BLADE WAS CUTTING THROUGH THE FEMORAL HEAD. THE PATIENT'S INTERTROCHANTERIC FRACTURE WAS HEALED. THE ORIGINAL IMPLANT WAS ON (B)(6) 2020. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 95MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11670528 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA HELICAL BLADE AND UNKNOWN LOCKING SCREW FOR TOTAL HIP REPLACEMENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 95MM THIS REPORT IS 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616694 ↗
• InjuryAug 26, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM AND WAS REVISED TO A SHORTER UNKNOWN LAG SCREW DUE TO LATERAL PROTRUSION OF THE HELICAL BLADE. THE TFNA SYSTEM WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. PATIENT HAD CLINICAL FINDINGS OF DECREASED RANGE OF MOTION. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS OKAY. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 10453329 ↗
• InjuryMay 5, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) BLADE HAD PENETRATED MEDIALLY TO THE FEMORAL HEAD AS CONFIRMED BY X-RAYS TAKEN ON AN UNKNOWN DATE. THE PATIENT WALKED INTO THE OFFICE WITH A WALKER AND NO SIGNS OF PAIN. THE REVISION SURGERY WAS DONE ON (B)(6) 2020. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1, UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1, UNKNOWN END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10027050 ↗
• InjuryMar 27, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) HELICAL BLADE EXCHANGE DUE TO EXCESS GUIDED COLLAPSE LEADING TO PATIENT PAIN. IT WAS ORIGINALLY IMPLANTED IN OCTOBER 2019. SUCCESSFULLY REMOVE THE EXISTING HELICAL BLADE AND A SHORTER HELICAL BLADE WAS IMPLANTED. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 9889010 ↗

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