TFN-ADVANCE 04.038.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982098764), received between Oct 2, 2019 and Jul 8, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE TFNA NAIL APPROXIMATELY TWO MONTHS AGO. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO NONUNION OF INTER TROCHANTER AND A FRACTURE BELOW THE NAIL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 100MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19688712 ↗
• InjuryDec 21, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, A HARDWARE REMOVAL PROCEDURE FOR A HIP NAIL WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18377966 ↗
• InjuryDec 29, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A TFNA LAG SCREW WAS REMOVED IN A REVISION SURGERY DUE TO EXCESSIVE COLLAPSE OF THE LAG SCREW. THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16070676 ↗
• InjuryAug 1, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT CAME TO ER STATING THAT SHE HAD A GROUND LEVEL FALL AND WAS COMPLAINING OF INCREASE LEFT HIP PAIN. PATIENT HAD ORIGINAL TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) IMPLANTED ON (B)(6) 2022. SURGEON SCHEDULED A REVISION SURGERY ON (B)(6) 2022 FOR REMOVAL OF BROKEN HARDWARE WHICH WAS CONFIRMED BY ER X-RAYS ON (B)(6) 2022. HARDWARE WAS REMOVED AND A TROCHANTERIC FIXATION NAI (TFN) WAS CHOSEN FOR THE REPAIR BECAUSE THE TFN HAD A LARGER DIAMETER PROXIMAL BODY AND LAG SCREW. IMPLANTS WERE REMOVED AND DOCUMENTED AND TFN WAS IMPLANTED WITH SUCCESS. IT WAS DESCRIBED THAT IMPLANT FAILED AT PROXIMAL END OF NAIL, PROXIMAL TO LAG SCREW INSERTION HOLE. PATIENT EXPERIENCED AN ADVERSE EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15140463 ↗
• MalfunctionAug 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL WAS BROKEN, TFNA FENESTRATED SCREW WAS DEFORMED AND AIMING ARM WAS STRIPPED WHEN RECEIVED AS A BLIND UNIT. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318118 ↗
• InjuryDec 15, 2020Adverse 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 WENT ON TO A NON-UNION THAT CAUSED THE IMPLANTS TO FAIL. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11012885 ↗
• InjuryAug 11, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) SHORT NAIL WAS REMOVED BECAUSE THE SCREW BROKE AT THE THREADS. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10392492 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO NON-UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SYSTEM ON AN UNKNOWN DATE. THE SURGEON REMOVED THE 130 DEGREES RIGHT ANGLE TFNA NAIL AND THE TFNA LAG/ FENESTRATED SCREW. THERE WAS NO SURGICAL DELAY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A 95 DEGREE CONDYLAR BLADE PLATE. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 100MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

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

  MAUDE report 9145061 ↗

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