TFN-ADVANCE 04.037.157SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982096654), received between Jul 26, 2018 and Oct 23, 2025 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INTER-LOCKING MECHANISM OF THE NAIL WAS NOT ADVANCED, SO A NEW NAIL WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367936 ↗
• InjuryAug 18, 2025Break; Break

  TFNA BREAKAGE AT LAG SCREW INTERFACE DOI (B)(6) 2025 DOR (B)(6) 2025. NO PRODUCT RETURN NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22834597 ↗
• InjuryOct 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR CONVERSION TO TOTAL HIP DUE TO CUT OUT. THERE WAS NO SURGICAL DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 360MM/LEFT - STERILE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15620836 ↗
• InjuryJun 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) WITH FAILURE AT THE LAG SCREW SITE. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TFNA FENESTRATED SCREW (PART: 04.038.190S, LOT: H831463, QUANTITY: 1). THIS REPORT IS FOR A 11 MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10115307 ↗
• InjurySep 10, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS BROKEN, THE SALES CONSULTANT WAS CALLED TO ASSIST WITH THE REMOVAL AND REVISION OF THE DEVICE. THERE WAS A NON UNION ON THE POSTOPERATIVE EVENT. THERE WAS NO SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAYBE DEFICIENCY WITH THE PRODUCT. THE DEVICE WAS EXPLANTED. FRAGMENTS WERE GENERATED DUE TO THE BROKEN DEVICE, THE REMOVAL OF THE BROKEN, DAMAGED DEVICE OR FRAGMENTS WAS EASILY REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME WERE SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNKNOWN LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN NAIL HEAD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) 11 MM/130 DEG TI CANN TFNA 360 MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8982785 ↗
• InjuryJul 26, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A BROKEN TROCHANTERIC FEMORAL NAIL-ADVANCE (TFNA) NAIL. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE TFNA NAIL ON (B)(6) 2018 TO TREAT A REVERSE OBLIQUE INTERTROCHANTERIC / SUBTROCHANTERIC FRACTURE. ON (B)(6) 2018, AN X-RAY SHOWED AN INTACT NAIL BUT ON (B)(6) 2018 THE NAIL WAS BROKEN AS REVEALED ON THE X-RAY. THE TFNA PROXIMAL NAIL WAS BROKEN JUST ABOVE THE HELICAL BLADE. THERE WAS NO MALFUNCTION OF THE BLADE OR DISTAL LOCKING SCREW. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CURRENT PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); DISTAL LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 11 MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA 360 MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7721765 ↗

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-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