TFN-ADVANCE 04.038.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982098986), received between Feb 4, 2019 and Apr 13, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA), ONE (1) TITANIUM LOCKING SCREW, ONE (1) TFNA HELICAL BLADE AND ONE (1) TFNA END CAP BECAUSE THE FEMUR BROKE BELOW WHERE THESE IMPLANTS SAT. IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2020. SHE WAS INITIALLY SEEN FOR AN INTERTROCHANTERIC HIP FRACTURE. ALL IMPLANTS ARE SUCCESSFULLY REMOVED AND WERE REVISED TO A LONG TFNA AND WERE ALSO AUGMENTED FIXATION WITH A TRAUMA CEMENT. THE PATIENT OUTCOME WAS SUCCESSFUL WITH NO CONCERNS. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS (PART NUMBER 04.005.524, LOT UNKNOWN, QUANTITY 1), 11MM/130 DEG TI CANN TFNA 170MM ¿ STERILE (PART NUMBER 04.037.142S, LOT UNKNOWN, QUANTITY 1), END CAPS: TFNA ( UNKNOWN PART NUMBER, UNKNOWN LOT, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA HELICAL BLADE 90MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9953386 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8819526 ↗
• InjuryFeb 4, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT A TFNA NAIL REMOVAL DUE TO HELICAL BLADE CUT-OUT. DURING THE SURGERY, A TFNA NAIL, HELICAL BLADE AND SCREW WERE REMOVED. THE SURGEON IMPLANTED A TOTAL HIP REPLACEMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: CANNULATED TFNA NAIL (PART 04.037.061S, LOT H601850, QUANTITY 1). LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8301783 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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