TFN-ADVANCE 04.037.060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982096166), received between Aug 14, 2019 and Sep 3, 2024 — 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 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A HIP SURGERY, THE FLEX AND TORQUE SCREWDRIVER ALONG WITH THE STRAIGHT SHAFT AND WRENCH COULD NOT GET THROUGH THE CONNECTING SCREW TO ENGAGE THE LOCKING MECHANISM OF THE TFNA NAIL. A NEW NAIL AND DIFFERENT CONNECTING SCREW WERE USED TO COMPLETE THE CASE. THERE WAS A DELAY OF 4-5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128540 ↗
• InjuryApr 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A REMOVAL SURGERY FOR A BROKEN TFNA. THE REMOVAL CASE WAS FOR A NONUNION/INFECTION OF THE FRACTURE, WHICH WAS ALSO A REVISION NAIL FROM A PREVIOUS CASE. THE PATIENT WAS FEMALE OF SLIGHT BUILD, PROBABLY AROUND 60-70KG. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE UNK - NAILS: TFNA. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 16663387 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, THAT A REVISION OF A TFNA WILL BE PERFORMED IN 05/0P. THE TFNA NAIL WAS SUCCESSFULLY REMOVED AND REPLACED. THE REASON FOR THE EXCHANGE WAS A NON UNION OF THE FRACTURE SIDE OF THE FEMORAL SHAFT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS/ OUTCOME: STABLE. THIS REPORT IS FOR ONE (1) 10/130 DEG TI CANN TFNA 400/RIGHT - SILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14884644 ↗
• InjuryAug 14, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF THE BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) FEMORAL NAIL DUE TO DELAYED HEALING AND NONUNION. HARDWARE WAS IMPLANTED IN (B)(6) 2018. THE FRAGMENTS FROM THE BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) FEMORAL NAIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), LOCKING SCREW (PART 04.005.530, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8892991 ↗

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