TFN-ADVANCE 04.038.385SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982099235), received between Feb 5, 2019 and Dec 11, 2025 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Migration” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, DUE TO THE TFNA HELICAL BLADE CUT THROUGH INTO ACETABULUM, THE BLADE WAS REMOVED AND WAS REPLACED WITH LAG SCREW. HARDWARE EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782302 ↗
• InjurySep 12, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS WITH TFNA FOR FEMORAL TROCHANTER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, THE X-RAY REVEALED CUT-OUT. ON (B)(6) 2024, A REMOVAL SURGERY WAS PERFORMED. SINCE THE PATIENT IS ELDERLY AND INACTIVE, NO NEW FIXATION WAS PERFORMED. THE PATIENT HAS NOT BEEN FOLLOWED UP FOR MORE THAN 1 YEAR AFTER SURGERY, SO THAT THE CAUSE OF THE CUT-OUT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20204777 ↗
• MalfunctionAug 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, THE DISTRIBUTOR FOUND THE LOT NUMBER ON THE IMPLANTS ARE DIFFERENT FROM THE LOT ON THE PRODUCT PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 9 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064933 ↗
• MalfunctionAug 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, THE DISTRIBUTOR FOUND THE LOT NUMBER ON THE IMPLANTS ARE DIFFERENT FROM THE LOT ON THE PRODUCT PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064932 ↗
• MalfunctionAug 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, THE DISTRIBUTOR FOUND THE LOT NUMBER ON THE IMPLANTS ARE DIFFERENT FROM THE LOT ON THE PRODUCT PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 8 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064931 ↗
• MalfunctionAug 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, THE DISTRIBUTOR FOUND THE LOT NUMBER ON THE IMPLANTS ARE DIFFERENT FROM THE LOT ON THE PRODUCT PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064930 ↗
• MalfunctionAug 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON JULY 26, 2024, THE DISTRIBUTOR FOUND THE LOT NUMBER ON THE IMPLANTS ARE DIFFERENT FROM THE LOT ON THE PRODUCT PACKAGES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064834 ↗
• InjuryAug 22, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE SURGERY, UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 85 - SILE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 20031667 ↗
• MalfunctionOct 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886725 ↗
• MalfunctionApr 3, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICE WAS DEFECTIVE. THE PRODUCT WAS SHIPPED IN STERILE PACKAGING AND WAS FOUND TO BE DAMAGED. IT WAS NOT IMPLANTED IN A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662907 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY FOR CERVICAL BASE FRACTURE WITH THE PRODUCTS IN QUESTION. THE PATIENT HAD BEEN ABLE TO UNDERGO AN EXTRAMEDULLARY REPAIR, BUT WAS SHIFTED TO INTRAMEDULLARY AFTER SURGERY, AND IS NOW ON THE VERGE OF AN ENDOPROSTHETIC CUTOUT. AN ARTIFICIAL HEAD REPLACEMENT WAS PERFORMED ON (B)(6) 2022. THE CAUSE IS UNKNOWN BECAUSE NO POSTOPERATIVE CT WAS TAKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 85MM ¿ STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15715756 ↗
• InjuryMar 4, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MEETING OF THE AOTC HELD ON (B)(6) 2021, SLIDES WERE PRESENTED WHICH REPRESENTED FOUR TFNA CASES WITH MEDIAL BLADE MIGRATION INTO THE PELVIC AREA. ALL FOUR CASES WERE REVISED TO A PROSTHESIS. THIS CAPTURES THE CASE WITH PATIENT: FEMALE, (B)(6) YEARS OLD AT TIME OF EVENT. PATIENT HAD BEGUN TO COMPLAIN OF PAIN AT THE END OF (B)(6) 2021. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 85MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Pain

  MAUDE report 13666584 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO PAIN. THERE WAS NO BROKEN IMPLANT REPORTED. THE SURGEON THEN CONVERTED PATIENT TO A TOTAL HIP ARTHROPLASTY. REMOVED HARDWARE SUCCESSFULLY. PATIENT CONSEQUENCE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Arthritis; Pain

  MAUDE report 13481249 ↗
• InjuryJun 23, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION OF THE HELICAL BLADE DUE TO A CUT THROUGH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN TFNA NAIL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 12053059 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT A HARDWARE REMOVAL FROM THE LEFT HIP. THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, UNKNOWN 85MM HELICAL BLADE, UNKNOWN DISTAL LOCKING SCREW WERE REMOVED DUE TO AN UNKNOWN REASON. THE REPORTER COMMENTED THAT THE X-RAY REVEALED AN AUGMENT OF CEMENT PRESENT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11089494 ↗
• InjuryJun 9, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON STATICALLY LOCKED THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE 85MM STERILE. POST-OPERATIVE FOLLOW-UP FILMS SHOW THAT THE HELICAL BLADE HAS COLLAPSED AND THE PATIENT HAS LOST SOME REDUCTION CAUSING A DELAYED UNION. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS (B)(4) PERTAINS TO CASE 1 AND COMPLAINT IS REFERENCE TO THE THIS (B)(4) FOR THE OTHER CASE. CONCOMITANT DEVICE REPORTED: 11MM/130 DEG TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) 420MM/RIGHT - STERILE (PART# 04.037.162S; LOT# H234696, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 10135744 ↗
• 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 TFNA FENESTRATED HELICAL BLADE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8469078 ↗
• InjuryFeb 5, 2019Migration; Migration

  3/15/2019: UPDATED INFORMATION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE PATIENT PRESENTED WITH SEVERE PAIN ON (B)(6) 2019 AND THE IMPLANT WAS OBSERVED TO HAVE CUT OUT OF THE BONE. THE ORIGINAL DATE OF THE OPERATIVE FIXATION OF RIGHT PROXIMAL FEMUR WAS ON (B)(6) 2019. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS IS STABLE

  Patient problems: No Code Available; Pain

  MAUDE report 8307045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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