TFN-ADVANCE 04.037.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982095848), received between Jan 18, 2019 and Jan 2, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE A BROKEN NAIL AND NON-UNION. THE NAIL BROKE AT THE NAIL/LAG SCREW INTERFACE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2024. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 21059894 ↗
• MalfunctionMay 8, 2023Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE SCREWDRIVER FAILED. THE SCREWDRIVER DID NOT ALLOW FOR A CORRECT ASSEMBLY OF THE HELICAL BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 10 MINUTE DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/125 DEG TI CANN TFNA 360MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885731 ↗
• InjuryAug 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL OF A BROKEN TFNA NAIL. IT WAS BROKEN AT THE OPENING OF THE HELICAL BLADE. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: HELICAL BLADE (PART # 04.038.385S, LOT # 691694, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10413287 ↗
• InjuryJun 29, 2020Migration; Migration

  CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW 80MM - STERILE (PART NUMBER 04.038.180S, LOT 10L0755, QUANTITY 1); LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10205869 ↗
• InjuryFeb 27, 2019Break; Break

  UPDATED CONCOMITANT DEVICE: LOCKING SCREW (PART 04.005.530, LOT UNKNOWN, QUANTITY 1).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8374626 ↗
• InjuryJan 18, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT IMPLANT PROCEDURE. ON (B)(6) 2018, A PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL BECAUSE IT BROKE IN THE PATIENT. DURING THE REMOVAL PROCEDURE, SCREW/BLADE EXTRACTION DEVICE WAS DAMAGED AND BROKE AT THE TIP. FRAGMENTS WERE GENERATED AND CAME OUT IN ONE PIECE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS (B)(4) CAPTURES THE POSTOPERATIVE EVENT WHILE (B)(4) CAPTURES THE INTRAOPERATIVE EVENT WHERE A SCREW/BLADE EXTRACTION DEVICE WAS DAMAGED AND BROKE AT THE TIP DURING A REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA). CONCOMITANT DEVICES: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8261879 ↗

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-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-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-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