TFN-ADVANCE 04.037.062SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982096180), received between May 23, 2019 and Apr 14, 2026 — classified as 2 injuries, 2 malfunctions.

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.

• MalfunctionApr 14, 2026Material Discolored; Material Deformation

  IT WAS REPORTED THAT THERE WAS A BOX DAMAGED ON TFNA NAILS, AND OTHER INSTRUMENTS NEED REPLACEMENT. ITEMS WERE BENT AND THERE WERE FADED HANDLES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871268 ↗
• MalfunctionMar 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING AN IT FIX IN A LARGE PATIENT, THE STEP REAMER KEPT HITTING THE NAIL. THE SURGEON TOOK THE NAIL OUT AND USED ONE OF A LARGER SIZE, AND USED A PERC HANDLE TO SEE IF IT WOULD CHANGE. THIS APPROACH WORKED AND THE 10X420 R NAIL WAS NOT IMPLANTED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 420MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953966 ↗
• InjuryOct 12, 2023Break; Break

  OTHER CLINICAL FINDINGS: NON-UNION.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17923763 ↗
• InjuryMay 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO NONUNION OF THE RIGHT FEMUR WITH A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL. HARDWARE WAS IMPLANTED APPROXIMATELY A YEAR AGO. THE PATIENT WAS REVISED WITH AN ANGLE BLADE PLATE AND BONE GRAFTING. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA SCREW (PART # 04.038.100, LOT#7959062, QUANTITY # 1); UNKNOWN DISTAL LOCKING SCREWS (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 8637641 ↗

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-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-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