TFN-ADVANCE 04.038.185Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982098702), received between Aug 28, 2020 and Oct 3, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Adverse 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 WAS DIAGNOSED DUE TO INFECTION AND UNDERWENT HARDWARE REMOVAL. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 85MM.

  Patient problems: Unspecified Infection

  MAUDE report 20359434 ↗
• InjuryFeb 10, 2022Break; Break

  IT WAS REPORTED THAT, THE TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) IMPLANT BROKE. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 85MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13507505 ↗
• InjuryApr 7, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE TFNA NAIL REMOVED DUE TO NON-UNION AND THE SCREW MIGRATING INTO THE PATIENT'S HIP JOINT. THE SURGEON REMOVED THE IMPLANTS WITHOUT ISSUE. THE PATIENT THEN RECEIVED A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: TFNA FEM NAIL Ø11 130° L170 TIMO15 (PART:04.037.142S,LOT: H808409, QUANTITY:1), LOCKSCR Ø5 SELF-TAP L36 TAN (PART: 458.936, LOT:7373512,QUANTITY:1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11631101 ↗
• MalfunctionOct 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY (IM) NAILING OF INTERTROCHANTERIC FRACTURE PROCEDURE ON (B)(6) 2020, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED SCREW GOT STUCK IN THE TFNA NAIL AND COULD NOT BE ADVANCED OR PULLED BACK. THE NAIL WAS ABLE TO BE REMOVED AND EXCHANGED WITH ANOTHER NAIL. A SECOND TFNA SET WAS USED TO PROCEED WITH THE CASE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA SCREW INSERTER (PART # 03.037.025 LOT # L503499, QUANTITY 1), CONNECTING SCREW FOR TFNA HELICAL BLADE AND SCREW (PART # 03.037.026 LOT # L987541, QUANTITY 1), EXTRACTION INSTRUMENT FOR TFNA HELICAL BLADE AND SCREW (PART # 03.037.030, LOT # 534061, QUANTITY 1); 11MM/125 DEG TI CANN TFNA 235MM/LEFT, STERILE (PART # 04.037.115S, LOT # 49P4912, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621557 ↗
• InjuryAug 28, 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 UNDERWENT THE REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTS DUE TO HIP ARTHRITIS AND DECREASED RANGE OF MOTION (ROM). THE PATIENT WAS THEN REVISED WITH A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 10465595 ↗

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