TFN-ADVANCE 04.037.955SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982098153), received between Sep 12, 2019 and Oct 15, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON`S PATIENT PRESENTED WITH A BROKEN TFN-ADVANCED SYSTEM, LONG NAILS, 9MM DISTAL DIAMETER AT THE LAG SCREW/HELICAL BLADE INSERTION JUNCTION. THE ORIGINAL SURGERY WAS DONE IN 2017 TO TREAT A CANCEROUS LESION. THE 85MM LAG SCREW WAS STILL IN TACT AS WELL THE 40MM DISTAL LOCKING SCREW. THE SURGEON SUCCESSFULLY REMOVED ALL IMPLANTS, INCLUDING THE BROKEN TFNA NAIL. NO HARDWARE REMAINED IMPLANTED. A 10X340, 130 DEGREE TFNA NAIL, 85MM LAG SCREW, AND A 40MM AND 48MM LOCKING SCREWS WERE IMPLANTED SUCCESSFULLY TO ADDRESS THE PATIENTS DELAYED NON-UNION. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEM: TFNA LAG SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - SCREW:LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR 1 9MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10684666 ↗
• InjurySep 12, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL FEMUR DUE TO A BROKEN TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL AND A NON-UNION. INITIALLY, THE PATIENT HAD IMPLANTATION IN (B)(6) 2018. DURING REVISION, UPON SETTING UP THE CASE THE X-RAYS REVEALED A BROKEN TFNA FEMORAL NAIL AND NON-UNION FEMUR. THE BROKEN TFNA FEMORAL NAIL, UNKNOWN LAG SCREW AND UNKNOWN LOCKING BOLT WERE THEN REMOVED AND WAS INSERTED WITH A 95 DEGREE ANGLE BLADE PLATE. THE IMPLANTS WERE IS SUCCESSFULLY EXPLANTED WITHOUT ANY COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW (PART# 04.038.200, LOT# H610669, QUANTITY 1) AND UNKNOWN LOCKING BOLT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9009137 ↗

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-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-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-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