TFN-ADVANCE 04.037.245SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982097293), received between Apr 1, 2019 and Sep 11, 2023 — classified as 3 injuries, 1 malfunction.

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.

• MalfunctionSep 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 23-AUGUST-2023, THE SURGEON USED A SHORT TFNA NAIL ON THE PATIENT. IT WAS ATTEMPTED TO HAMMER THE HELICAL BLADE THROUGH THE NAIL USING THE JIG, BUT THE BLADE WAS UNABLE TO PASS THROUGH THE NAIL. IT WAS PREVIOUSLY TESTED USING A GUIDEWIRE AND DRILL BIT. THE NAIL WAS REMOVED AND A LONG NAIL WAS IMPLANTED WITH NO ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719819 ↗
• InjuryOct 17, 2022Break; Break

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE A BROKEN TFNA NAIL. THE NAIL WAS ORIGINALLY IMPLANTED IN (B)(6) OF 2022, NO SPECIFIC CAUSE IS KNOWN FOR THE NAIL BREAKAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15614203 ↗
• InjuryDec 3, 2020Break; Break

  ADDITIONAL CONCOMITANT DEVICE: 11.0MM TI HELICAL BLADE 100MM (PART 456.305, LOT H029260, QUANTITY 1).

  Patient problems: Failure of Implant

  MAUDE report 10942847 ↗
• InjuryApr 1, 2019Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY REVISION ON (B)(6) 2019, DUE TO TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) AUGMENTATION CUTOUT. THE WHOLE CONSTRUCT CUT OUT OF THE BONE. THE INITIAL IMPLANT WAS ON (B)(6) 2019. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: DISTAL LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8469150 ↗

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