TFN-ADVANCE 04.037.228SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982097149), received between Feb 13, 2018 and Jan 22, 2021 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A PROXIMAL FEMUR FRACTURE THAT WAS TREATED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2020, AND THE PATIENT FAILED TO HEAL. THE SURGEON DECIDED TO CONVERT THE PATIENT TO A TOTAL HIP REPLACEMENT SURGERY. REMOVAL OF THE TFNA WAS REQUIRED TO PROCEED WITH THE DESIRED PROCEDURE DUE TO NON-UNION. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11214576 ↗
• InjuryMar 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) A LONG TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS INSERTED WITH A LAG BLADE IN THE FEMORAL HEAD AND DISTAL LOCKING WAS COMPLETED. ON VIEWING THE FINAL X-RAYS, IT WAS DISCOVERED THE LAG BLADE HAD MISSED THE NAIL. THIS WAS SUBSEQUENTLY REMOVED, THE JIG AND HANDLE WERE RECONNECTED, AND A NEW BLADE WAS INSERTED. CONCOMITANT DEVICES: LOCKING SCREW (PART: 04.005.528S, LOT: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART: 04.005.530S, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TFNA HELICAL BLADE (PART: 04.038.390S, LOT: 10L0160, QUANTITY: 1), GUIDE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), K-WIRE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 12MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9812740 ↗
• DeathOct 8, 2018Break; Break

  HARDWARE REMOVAL OCCURRED ON (B)(6) 2018. PATIENT DIED ON (B)(6) 2018. CONCOMITANT DEVICES: HELICAL BLADE (PART: 04.038.290S, LOT: H279255, QUANTITY: 1), 5.0MM TITANIUM (TI) LOCKING SCREW 38MM (PART: 04.005.528, LOT: UNKNOWN, QUANTITY: 1), 5.0MM TI LOCKING SCREW 40MM (PART: 04.005.530, LOT: UNKNOWN, QUANTITY: 1).

  Patient problems: Death; Failure of Implant

  MAUDE report 7942421 ↗
• InjuryFeb 13, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT UNDERWENT A REVISION OF ONE (1) TFNA NAIL, ONE (1) TFNA LAG SCREW, ONE (1) TFNA DISTAL LOCKING SCREW AND TWO (2) UNKNOWN CABLES ON (B)(6) 2018 TO UNKNOWN ZIMMER IMPLANTS DUE TO ONE BROKEN (1) TFNA NAIL, TWO (2) BROKEN CABLES AND NONUNION. THE PATIENT WAS INITIALLY SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS IMPLANTED WITH THE TFNA CONSTRUCT ON AN (B)(6) 2017 FOR AN UNKNOWN TIBIAL FRACTURE. THE CABLES WERE WRAPPED AROUND THE FRACTURE, JUST DISTAL TO THE LAG SCREW AND TFNA INTERFACE. SUBSEQUENTLY, POST OPERATIVE X-RAYS SUGGESTED THAT THE TFNA NAIL WAS BROKEN AT THE TFNA NAIL AND LAG SCREW INTERFACE, AND THAT THE CABLES LOCATED JUST BELOW THIS BREAK WERE ALSO MANGLED/BROKEN. THE NAIL WAS DESCRIBED TO HAVE BEEN BROKEN IN TWO CLEAN PIECES AND WAS REMOVED AS SUCH. ALL IMPLANTS WERE REMOVED VERY EASILY, SUCCESSFULLY AND WITHOUT ANY COMPLICATIONS OR ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA LAG SCREW (PART# 04.038.100S, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN TFNA DISTAL LOCKING SCREW (PART# 04.005.536S, LOT# UNKNOWN, QUANTITY# 1). (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7266883 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, 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
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima