TFN-ADVANCE 04.037.033SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982095916), received between May 10, 2019 and Apr 1, 2024 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO IMPLANT THE TFNA WITH BLADE ON (B)(6) 2023. THE SUBTROCHANTERIC FRACTURE WAS REDUCED AND OSTEOSYNTHESISED WITH A LONG TFNA NAIL. THE PATIENT WAS SEEN AGAIN AS PART OF HIS FOLLOW-UP CONSULTATION AND HAD RESUMED WEIGHT-BEARING WITHOUT TOO MUCH DIFFICULTY FOR SEVERAL WEEKS. IT WAS NOTED ON IMAGING ON (B)(6) 2024 THAT THE BLADE HAS MIGRATED INTO THE ACETABULUM DESPITE LOCKING THE SCREW DURING THE INITIAL SURGERY. THE PATIENT UNDERWENT A REVISION AND WAS CONVERTED TO AN HSP WITH FEMORAL CERCLAGE (NOT SOLID AT TWO MONTHS). THE DEVICE WAS EXPLANTED ON (B)(6) 2024. THIS REPORT IS FOR A 10MM/125 DEG TI CANN TFNA 420MM/LEFT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012674 ↗
• InjuryMay 10, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, PATIENT UNDERWENT DEVICE REMOVAL DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) NAIL. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2), TFNA FENESTRATED SCREW 95MM (PART: 04.038.195, LOT: H691521, QUANTITY: 1). THIS REPORT IS FOR A 10MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8601310 ↗

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-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
• 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-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-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