TFN-ADVANCE 04.037.044SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982096005), received between Oct 15, 2018 and Sep 9, 2026 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  It was reported that a TFNA nail has broken. No further information is provided.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 50696409 ↗
• InjuryMar 31, 2026Break

  IT WAS REPORTED THROUGH A GERMAN HEALTH AUTHORITY USER REPORT. THE NAIL FRACTURED IN A CASE OF PSEUDARTHROSIS OF THE FORMER FRACTURE (FAILURE TO HEAL THE FRACTURE). PATIENT OUTCOME WAS REPORTED AS GOOD FUNCTIONAL OUTCOME, PAIN BEFORE IMPLANT EXCHANGE, NONUNION FORMATION, NO INFECTION. IMPLANT DATE: (B)(6) 2025.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 24746475 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING HIP FRACTURE SURGERY USING THE TFNA SYSTEM, IT WAS IDENTIFIED THAT THE TFNA NAIL WAS UNABLE TO BE ATTACHED TO THE INSERTION HANDLE DUE TO THE SMALL METAL TAB AT THE PROXIMAL END OF THE NAIL WAS BENT INWARD SLIGHTLY. THE STAFF PUT THE DEFECTIVE IMPLANT TO THE SIDE AND OPENED ANOTHER OF THE SAME IMPLANT. THE SURGERY THEN PROCEEDED WITHOUT ANY ISSUES. THERE WAS NO PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718911 ↗
• InjuryDec 15, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THAT THE PROCEDURE, HWR + MALREDUCTION REVISION CEPHALOMEDULLARY NAIL WAS PERFORMED. DIAGNOSIS INCLUDED MALREDUCTION AND A BROKEN IMPLANT.

  Patient problems: Physical Asymmetry

  MAUDE report 23802232 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE PROCEDURE, THE BLADE COULD NOT BE INSERTED INTO THE NAIL DUE TO A BLOCKAGE IN THE BLADE HOLE, REQUIRING REMOVAL OF BOTH THE BLADE AND NAIL. THIS PROCESS WAS DIFFICULT, FRAGMENTS WERE GENERATED AND NOT REMOVED EASILY, AND A COMPLETE NEW NAIL AND BLADE WERE NEEDED. THE SURGERY WAS PROLONGED BY APPROXIMATELY 60 MINUTES BUT WAS ULTIMATELY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 23632893 ↗
• MalfunctionApr 9, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE SET SCREW WITHIN THE TFNA NAIL SEEMED TO BE FROZEN AND WOULD NOT ADVANCE. IMPLANTS HAD TO BE EXTRACTED AND REIMPLEMENTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 20 MINS. THIS REPORT IS FOR ONE 10/130 DEG TI CANN TFNA 235/RIGHT - SILE FOR (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 19074931 ↗
• InjuryDec 27, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN ORIF WITH THE TFNA FOR A FEMORAL SUBTROCHANTERIC FRACTURE. THE INDEX PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. BONE UNION WAS PROGRESSING MORE SLOWLY THAN USUAL AND WAS BEING FOLLOWED. IT WAS LATER CONFIRMED THAT THE NAIL WAS BROKEN AT THE DISTAL LOCKING SCREW AREA. A REVISION PROCEDURE WAS SCHEDULED FOR (B)(6) 2023 TO REMOVE THE BROKEN NAIL AND REPLACE IT WITH A LONG NAIL. BONE GRAFTS WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18397967 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED A TFNA CONSTRUCT FROM THE PATIENT BECAUSE OF SOFT TISSUE ISSUES AND PAIN. IT IS UNKNOWN IF THE HARDWARE CAUSED THE SOFT TISSUE PROBLEMS. THE CONSTRUCT WAS IMPLANTED APPROXIMATELY 6-9 MONTHS AGO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17446502 ↗
• InjuryOct 18, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A TFNA REMOVAL WHERE THE BLADE HAS MIGRATED MEDIAL. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS REPORT IS 1 OF 2 OF (B)(4).

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

  MAUDE report 12647293 ↗
• MalfunctionAug 17, 2021Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330820 ↗
• MalfunctionJul 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON HAD LOCKED THE PROXIMAL LOCKING INTERLOCKING MECHANISM IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). THE TFNA SYSTEM, SHORT NAIL, LOCKED ITS INTERLOCKING MECHANISM TO THE UNKNOWN BLADE IN THE UNKNOWN SCREW. THE SURGEON WANTS TO INSERT THE PROXIMAL BLADE OR SCREW OPTION AND THE INTERLOCKING MECHANISM WHICH WAS NOT ALLOWING THE SCREW BLADE TO ENGAGED. THE SURGEON HAD TIGHTENED THE INTERLOCK BEFORE PUTTING IT ON THE INSERTION HANDLE. THEN, WHEN PUTTING IN THE PROXIMAL BLADE, AND HAD ISSUES BECAUSE THE LOCKING MECHANISM WAS ALREADY DOWN. IT WAS IN THE PATIENT WHEN THE NAIL WAS IMPROPERLY ENGAGED, BUT IT WAS REMOVED AND GOT A NEW NAIL. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. UNKNOWN INSERTION HANDLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 10/130 DEG TI CANN TFNA 235/RIGHT - SILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249166 ↗
• InjuryApr 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY WAS PERFORMED. THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL FAILED AND BROKE AT THE JUNCTION OF THE HELICAL BLADE. THIS RESULTED IN A REVISION SURGERY ON (B)(6) 2019, TO REMOVE THE BROKEN NAIL AND IMPLANT A LONG NAIL. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNK - NAIL HEAD ELEM: TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNK - END CAPS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8479412 ↗
• InjuryOct 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS ORIGINALLY IMPLANTED WITH TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) 10X130X235 NAIL, 95MM HELICAL BLADE, AND A 34MM LOCKING SCREW. ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR DUE TO REMOVAL OF BROKEN TFNA NAIL THROUGH THE DISTAL SCREW HOLE. ALL TFNA IMPLANTS WERE REMOVED AND SUCCESSFULLY REPLACED WITH A TFNA 11X130X380 NAIL, 100MM HELICAL BLADE AND 38MM LOCKING SCREW. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAYS. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA FENESTRATED HELICAL BLADE 95MM - STERILE (PART # 04.038.395S , LOT # UNKNOWN, QUANTITY #1). 5.0MM TI LOCKING SCREW 34MM- FOR IM NAILS-STERILE (PART # 458.934S, LOT # UNKNOWN, QUANTITY #1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7966855 ↗

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-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