TFN-ADVANCE 04.037.459SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982097637), received between Aug 15, 2018 and Mar 11, 2024 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THERE WAS AN EXPLANTATION OF A NAIL BREAKAGE PERFORMED. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2023. NO BROKEN FRAGMENTS WERE LEFT WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18877114 ↗
• InjuryAug 3, 2020Break; Break

  UPDATED ED: THE TWO LOCKING SCREWS THAT WERE REMOVED WERE COMPLETELY INTACT. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW L48MM (PART# 04.005.538S, LOT# UNKNOWN, QUANTITY# 2).

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

  MAUDE report 10359046 ↗
• InjuryJun 2, 2020Adverse 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 UNDERWENT A REVISION OF AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO ADDRESS A NON-UNION OF THE MID-SHAFT FEMUR PREVIOUSLY FIXATED WITH A 1 TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL 14MM LONG, 1 UNKNOWN 85MM LAG SCREW AND 2 TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS. THE PREVIOUS SURGERY WAS PERFORMED IN 2017. THERE WAS NO BROKEN HARDWARE PRESENTED, BUT A SUSPECTED INFECTION WAS PRESENT WHICH MAY HAVE CAUSED THE NON-UNION. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, UNKNOWN LAG SCREW, AND TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS WERE SUCCESSFULLY REMOVED WITHOUT BREAKAGE. THE SYNTHES RIA SYSTEM WAS USED TO CLEAR THE FEMORAL CANAL OF ANY PRESENT INFECTION. 10CC OF NORIAN WAS THEN IMPLANTED INTO THE PROXIMAL FEMUR WHERE THE PREVIOUS UNKNOWN LAG SCREW SAT. A 9X380 FRN-GT NAIL WAS OPENED AND ANTIBIOTIC CEMENT WAS WRAPPED AROUND THE NAIL. THE NAIL WAS THEN INSERTED INTO THE FEMUR TO ADDRESS THE NON-UNION. THE NAIL WAS LOCKED PROXIMALLY USING ONE 6.5 RECON SCREW AND ONE 5.0 LOCKING SCREW. THE NAIL WAS ALSO DISMALLY LOCKED USING TWO 5.0 INTERLOCKING SCREWS. THE PROCEDURE O

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

  MAUDE report 10109266 ↗
• InjuryMay 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN TROCHANTERIC FIXATION NAIL (TFN) NAIL AND HELICAL BLADE. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES ON DECEMBER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFN END CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINTS INVOLVES 2 DEVICES. THIS REPORT IS FOR 1 14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10022148 ↗
• InjuryAug 15, 2018Break; Break

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A SHORT PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) IN (B)(6) 2015 FOR A PROXIMAL FEMUR FRACTURE. FOLLOWING A FALL, PATIENT SUFFERED A PERIPROSTHETIC FEMUR FRACTURE AROUND THE PFNA. PATIENT WAS IMPLANTED WITH A LONG TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL ON (B)(6) 2017. PATIENT SUFFERED ANOTHER FALL AND ON (B)(6) 2018, X-RAY OF THE LEFT FEMUR REVEALED THE TFNA NAIL WAS BROKEN IN THE PROXIMAL SEGMENT OF THE NAIL AT THE HELICAL BLADE/NAIL INTERFACE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE NAIL, HELICAL BLADE, AND DISTAL LOCKING BOLT WERE REMOVED. PATIENT UNDERWENT A HEMIARTHROPLASTY WITH A LONG STEM HIP PROSTHESIS. THE HELICAL BLADE AND DISTAL LOCKING BOLT WERE REMOVED INTACT. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED HELICAL BLADE 100MM (04.038.400S, LOT H168655, QUANTITY 1), 5.0MM LOCKING SCREW WITH T25 STARDRIVE 50MM FOR IM NAIL (04.005.540S, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 14MM 130 DEGREE CANNULATED TFNA NAIL 380MM LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7784232 ↗

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-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-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-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