TFN-ADVANCE 04.037.163SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982096715), received between Dec 31, 2018 and Jun 10, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REMOVED A BROKEN LONG TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL (11MM X 420MM). THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14652188 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD A LONG TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL IMPLANTED 2 WEEKS AGO. THE PATIENT FELL POSTOPERATIVELY AND IMPLANTS NEEDED TO BE REMOVED AND REVISED TO A HEMIARTHROPLASTY. THE PROCEDURE AND THE PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14599847 ↗
• InjuryJan 3, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) NAIL AND NON-UNION ON (B)(6) 2019. ORIGINALLY, THE PATIENT HAD PRODUCT IMPLANTED IN (B)(6) 2018 FOR A PROPHYLACTIC INTRAMEDULLARY NAILING OF THE LEFT FEMUR. THE PATIENT HAD EXPERIENCED PAIN DUE TO THE BROKEN NAIL. THE BROKEN AND THE REST OF THE IMPLANTS WERE SUCCESSFULLY REMOVED AND REPLACED WITH A FEMORAL RECON NAIL WITH RECON SCREWS AND A LOCKING COMPRESSION PLATE (LCP) BROAD PLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 9546446 ↗
• InjuryAug 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO NONUNION AND DELAYED HEALING. THE NAIL WAS BROKEN AT THE LAG SCREW JUNCTION. THE LAG SCREW WAS INTACT. THE DISTAL LOCKING SCREW WAS BROKEN. ALL HARDWARE WAS REMOVED. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE BUT IT WAS REMOVED EASILY. THERE WAS A MEDICAL INTERVENTION REQUIRED TO TOTAL HIP INSERTION. THE ORIGINAL IMPLANT WAS ON (B)(6) 2019. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED SCREW (PART# 04.038.195S, LOT# H723308, QUANTITY# 1) . THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8905554 ↗
• InjuryJul 11, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT TROCHANTERIC FEMORAL NAIL (TFN) REVISION SURGERY DUE TO SEVERE PAIN AT THE SITE OF BREAKAGE. THE TROCHANTERIC FEMORAL NAIL-ADVANCED (TFNA) DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2018, FOR A PERI TROCHANTERIC FRACTURE USING A NAIL SIZE OF 11 X 420 LEFT WITH A 105 SCREW. THERE WAS ADDITIONAL MEDICAL INTERVENTION PERFORMED TO THE PATIENT HAVING PRESCRIPTIONS AND PHYSICAL THERAPY. FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND WAS DIFFICULT TO REMOVE DUE TO BROKEN NAIL IN TWO PIECES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED SCREW (PART #: 04.038.205, LOT #: H452577, QUANTITY #: 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8781398 ↗
• InjuryMar 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY THAT INVOLVES A LONG TROCHANTERIC FEMURAL NAIL SYSTEM (TFNA) DUE TO BROKEN AT NONUNION SITE. BROKEN NAIL WAS REMOVED AND NEW TFNA NAIL WAS IMPLANTED. REPORTEDLY NAIL WAS ORIGINALLY INSERTED APPROXIMATELY A YEAR AGO IN LEFT FEMUR FOR MYELOMA. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: TFNA HELICAL BLADE (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). TFNA SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8387973 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) HARDWARE WAS REMOVED DUE TO A FEMORAL NECK FRACTURE. BOTH THE TFNA NAIL AND LOCKING SCREWS WERE NOT BROKEN. THE PATIENT WAS REVISED/REPLACED WITH A HEMI-ARTHROPLASTY. THERE WAS AN UNSPECIFIED SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8206426 ↗

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-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-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