TFN-ADVANCE 04.037.061SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982096173), received between Aug 13, 2018 and Feb 20, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Break

  IT WAS REPORTED THAT PATIENT HAS A POSTOPERATIVELY BROKEN TFNA NAIL.

  Patient problems: Insufficient Information

  MAUDE report 24401192 ↗
• InjuryDec 23, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, HARDWARE WAS REMOVED DUE TO PROXIMAL FEMUR NONUNION AND A BROKEN TFNA. THERE WAS REVERSE OBLIQUE PROXIMAL FEMUR NONUNION. A NON-SYNTHES PRODUCT WAS UTILIZED FOR REVISION ALONG WITH A GRAFT FROM THE RIA2 SUPPLEMENTED BY VIVIGEN FORMABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16042843 ↗
• InjuryJun 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENTS TFNA NAIL BROKE. ON (B)(6) 2021 THE PATIENT UNDERWENT REVISION SURGERY, THE NAIL WAS REMOVED, AND A NEW NAIL WAS IMPLANTED. THERE WERE NO FRAGMENTS GENERATED. THIS REPORT INVOLVES ONE (1) 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11930317 ↗
• InjuryDec 12, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A NON-UNION OF A SUB-TROCH FEMUR FRACTURE THAT WAS ORIGINALLY TREATED WITH A LONG PROXIMAL FEMORAL NAILING SYSTEM (TFNA) ON (B)(6) 2020. THE PATIENT RECENTLY COMPLAINED OF SOME LEG PAIN AND AN X-RAY REVEALED A NON-UNION WITH A BROKEN TFNA LONG NAIL. THE NAIL WAS BROKEN AT THE HELICAL BLADE INSERTION OPENING IN THE NAIL. THE DISTAL LOCKING SCREW, TFNA HELICAL BLADE, BROKEN PROXIMAL AND DISTAL PIECE OF THE TFNA LONG NAIL WERE ALL REMOVED UNEVENTFULLY. THE PROCEDURE PROCEEDED AND REDUCTION AND FIXATION WERE ACHIEVED WITH A LOCKING COMPRESSION PLATE (LCP) PROXIMAL FEMUR HOOK AND AN ASSORTMENT OF LOCKING SCREWS AND CORTICAL SCREWS. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN DISTAL LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); TFNA FENESTRATED HELICAL BLADE (PART#: 04.038.375S, LOT#: H754413, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 10995840 ↗
• InjuryApr 23, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HAD TO BE REMOVED BECAUSE IT WAS BROKEN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN END CAPS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 10MM/ 130 DEG TI CANN TFNA 400MM/ LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9990284 ↗
• InjuryMay 31, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION AS THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) BROKE AT THE NAIL/HELICAL BLADE INTERFACE. PATIENT HAD A NON UNION FRACTURE, SO THE NAIL WAS REPLACED WITH ANOTHER TFNA. IN ADDITION, THE PATIENT ALSO HAD A 7 HOLE ONE THIRD TUBULAR PLATE PLACED ON THEIR ULNA WHICH ALSO BROKE POST-OPERATIVE. PATIENT NEEDED A NEW TFNA AND RECEIVED A DISTAL RADIUS PLATE ALONG WITH A 14 HOLE 3.5 CURVED LCP PLATE ON THEIR ULNA. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN.  CONCOMITANT DEVICE: DISTAL LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN); TFNA FENESTRATED HELICAL BLADE (PART 04.038.395, LOT UNKNOWN, QUANTITY UNKNOWN).  THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8659272 ↗
• InjuryApr 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT ARRIVED WITH A BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL IMPLANT. ORIGINAL SURGERY WAS DONE AT ANOTHER HOSPITAL. THE HIP FRACTURE WAS NOT UNITED AND THE NAIL BROKE AT THE JUNCTION OF THE TFNA FENESTRATED SCREW. ALL IMPLANTS WERE REMOVED. THE SURGEON THEN PROCEEDED WITH AN OSTEOTOMY AND PLACED A SMITH AND NEPHEW INTERTAIN NAIL. SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAIL HEAD ELEM: TFNA SCREW PERF (PART# 04.038.195S, LOT # H360241, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8531543 ↗
• InjuryAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE FOR A LEFT FEMUR SHAFT FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, THE FRACTURE WAS ANATOMICALLY REDUCED. SURGEON REAMED 1.5MM OVER THE DIAMETER OF THE NAIL. WHILE ATTEMPTING TO ROTATE THE NAIL WITHIN THE CANAL, SURGEON APPLIED HEAVY TORQUE TO THE AIMING ARM ATTACHED TO THE NAIL. WHEN THE LAG SCREW WAS DRILLED FOR AND IMPLANTED, THE LATERAL X-RAY CONFIRMED THE LAG SCREW WAS OUTSIDE THE NAIL. THE SCREW WAS REMOVED AND SURGEON REATTEMPTED TO TIGHTEN THE COUPLING SCREW BACK TO THE TOP OF THE NAIL TO THEN RE-INSERT THE LAG SCREW, BUT THE LAG SCREW STILL MISSED THE NAIL. SURGEON OPTED TO LEAVE THE LAG SCREW OUT AND USED TWO (2) DISTAL LOCKING SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THIS REPORT IS FOR ONE (1) 10MM 130 DEGREE CANNULATED TFNA NAIL THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7779445 ↗

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-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-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