TFN-ADVANCE 04.038.190Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982098726), received between Apr 18, 2018 and Dec 1, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 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 IMPLANTED A LONG TROCHANTERIC FIXATION NAIL- ADVANCED (TFNA) FOR A SUBTROCHANTERIC FEMUR FRACTURE. THERE WAS A NON-UNION AND THE NAIL EVENTUALLY BROKE. THE BROKEN NAIL, LAG SCREW, AND TWO DISTAL 5.0MM LOCKING SCREWS WERE REMOVED ON (B)(6) 2023. THE REVISION ENTAILED IMPLANTATION OF A GAMMA 3 NAIL, LAG SCREW, AND TWO DISTAL SCREWS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT IS FINE AND STABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18252462 ↗
• InjuryJul 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, A LONG TFNA NAIL WITH LAG SCREW BROKE AT THE JUNCTION OF THE LAG SCREW AND THE NAIL. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A TOTAL HIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 14976939 ↗
• InjuryApr 13, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REMOVAL OF TFNA LAG SCREW AND REPLACED WITH A HEMI. THE PATIENT GOT UP OFF THE TOILET AND FRACTURED HER TFNA LAG SCREW. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED. PATIENT STATUS IS NORMAL. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 90MM. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11659854 ↗
• InjuryFeb 5, 2021Migration; Migration

  IT WAS REPORTED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED. A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS PUT IN ABOUT A YEAR AGO AND THE LAG SCREW CUT OUT INTO THE FEMORAL HEAD. THE PATIENT CAME BACK WITH THE FAILED IMPLANT AFTER FALLING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 11287111 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A PROXIMAL FEMUR FRACTURE THAT WAS TREATED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2020, AND THE PATIENT FAILED TO HEAL. THE SURGEON DECIDED TO CONVERT THE PATIENT TO A TOTAL HIP REPLACEMENT SURGERY. REMOVAL OF THE TFNA WAS REQUIRED TO PROCEED WITH THE DESIRED PROCEDURE DUE TO NON-UNION. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11214588 ↗
• InjuryNov 19, 2020Break; Break

  IT WAS REPORTED THAT ON OCTOBER 22, 2020, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO TFNA FENESTRATED SCREW BROKE IN THE THREAD. DURING THE PROCEDURE THE TFNA NAIL, FENESTRATED SCREW AND A DISTAL LOCKING SCREW WERE REMOVED SUCCESSFULLY WITHOUT FURTHER DAMAGE AND THE PATIENT WAS REVISED TO A BIPOLAR HIP. THE FEMUR SPLIT DURING IMPLANTATION OF BIPOLAR HIP AND A CERCLAGE CABLE WAS USED TO STABILIZE THE FEMUR AND IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART #: 04.037.242, LOT #: H607959, QUANTITY: 1), UNKNOWN LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10869471 ↗
• InjuryAug 3, 2020Break; Break

  UPDATED ED: THE TWO LOCKING SCREWS THAT WERE REMOVED WERE COMPLETELY INTACT. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW L48MM (PART# 04.005.538S, LOT# UNKNOWN, QUANTITY# 2).

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

  MAUDE report 10358989 ↗
• InjuryJan 13, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL AND REVISION WITH A TOTAL HIP SURGERY DUE TO A BROKEN UNKNOWN TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) LAG SCREW. THE IMPLANT WAS SUCCESSFULLY REMOVED AND THEN A TOTAL HIP ARTHROPLASTY WAS PERFORMED ON THE PATIENT. THE PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); UNKNOWN TFNA LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9581745 ↗
• InjuryApr 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HARDWARE REMOVAL PROCEDURE FOR SUPERIOR CUT OUT OF LAG SCREW IN FEMORAL HEAD. NO COMPLICATIONS IN SURGERY. ALL THE HARDWARE WAS REMOVED. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART # 04.037.027S, LOT # UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCREW (PART # 04.005.526, LOT # UNKNOWN, QUANTITY 1; 5.0MM LOCKING SCREW(PART # 04.005.528, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7439750 ↗

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-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