TFN-ADVANCE 04.037.144SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982096562), received between May 11, 2018 and Aug 27, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

8 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.

Recalls naming this device

1. Jan 24, 2024Class IIOpen, Classified

   Products not sterilized, sterility cannot be confirmed

   Z-1240-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING THE PRE-OPERATIVE PHASE, A MALFUNCTION WAS OBSERVED IN THE LOCKING MECHANISM AT THE TOP OF THE DEVICE, WHICH IS DESIGNED TO SECURE THE BLADE. THE SYSTEM DID NOT FUNCTION AS INTENDED, PREVENTING PROPER FIXATION OF THE BLADE. CONSEQUENTLY, THE SURGICAL TIME DOUBLED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. ACTION WAS TAKEN, AND AN ALTERNATIVE IMPLANT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903979 ↗
• InjuryJun 5, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSTOPERATIVE NAIL DISASSOCIATION/ MEDIALIZATION OF TFNA HELICAL BLADE AT A FOLLOW UP VISIT AFTER HIP SURGERY. REVISION SURGERY WAS REQUIRED. REVISION TOTAL HIP ARTHROPLASTY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22148158 ↗
• InjuryJul 5, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE ON (B)(6) 2022, WHEN THE BLADE WAS INSERTED INTO THE NAIL IT BECAME STUCK HALFWAY. STAFF INDICATED THAT THE SET SCREW WAS HALF DEPLOYED INSIDE OF THE NAIL BEFORE THE NAIL WAS OPENED. THE NAIL WAS REMOVED AFTER 2 HOURS OF SURGERY, THE PATIENT REQUIRED BLOOD. THE DEFECTIVE IMPLANT WAS REMOVED, AND A NEW NAIL AND BLADE WERE INSERTED. THERE WAS A SURGICAL DELAY OF 120 MINUTES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 11MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14915245 ↗
• InjuryFeb 14, 2022Migration; Migration

  IT WAS REPORTED THAT, THE SURGEON IMPLANTED A 130-DEGREE TFNA NAIL WITH A LAG SCREW. POST-OPERATIVE MEASUREMENTS WERE TAKEN, AND HE MEASURED THE ANGLE BETWEEN THE NAIL AND THE LAG SCREW TO BE 123.9 DEGREES. NO REVISION SURGERY OR HARDWARE REMOVAL IS REQUIRED. THIS REPORT IS FOR (1) 11/130 DEG TI CANN TFNA 235/RIGHT - SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13525152 ↗
• InjuryJun 14, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT FELL AND FRACTURED HER HIP ON (B)(6) 2017 AND UNDERWENT SURGERY ON (B)(6) 2017. PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017, AND ENTERED A NURSING HOME. DURING A FOLLOW UP OFFICE VISIT ON (B)(6) 2017, X-RAYS SHOWED THE FRACTURE HAD SLIPPED. ADDITIONAL X-RAYS TAKEN ON (B)(6) 2017. PATIENT CONTINUED THERAPY AND WAS IN A WHEELCHAIR. PATIENT WAS DISCHARGED FROM THE NURSING HOME ON (B)(6) 2017 AND WAS IN A WHEELCHAIR FULL-TIME FOR ANOTHER 10 DAYS WHILE CONTINUING PHYSICAL THERAPY. PATIENT BEGAN USING A WALKER AT HOME ALONG WITH THE WHEELCHAIR ON (B)(6) 2017. X-RAYS WERE TAKEN DURING A FOLLOW UP OFFICE VISIT ON (B)(6) 2017. AT THAT TIME, PATIENT WAS WALKING WITH A CANE OR WALKER. X-RAYS TAKEN AGAIN ON (B)(6) 2017 DURING AN OFFICE VISIT. BETWEEN (B)(6) 2017 AND (B)(6) 2017, PATIENT WAS USING A CANE WHILE TRAVELING TO MAINE AND MASSACHUSETTS WHEN SHE FELT A SUDDEN INCREASE OF PAIN IN HER HIP. X-RAYS TAKEN ON (B)(6) 2017, DURING AN OFFICE VISIT, REVEALED A CRACK IN THE ROD (NAIL). PHYSICIAN RECOMMENDED A WALKER AND LIMITED ACTIVITY TO DECREASE PAIN AND TRACK HEALING. X-RAYS AND CONSULTATION ON (B)(6) 2017 CONFIRMED A CRACK IN NAIL, AND PHYSICIAN RE

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7602565 ↗
• InjuryMay 11, 2018Break; Break

  IT WAS REPORTED THAT A 11MM/130 DEG TI CANN TFNA (PROXIMAL FEMORAL NAILING SYSTEM) WAS IMPLANTED ON MAY 7, 2017. ON AN UNKNOWN DATE, THE NAIL BROKE.PATIENT UNDERWENT REVISION SURGERY AT A DIFFERENT FACILITY. DETAILS OF THAT PROCEDURE ARE UNKNOWN. PATIENT STATUS IS UNKNOWN.CONCOMITANT PRODICTS: TFNA HELICAL BLADE (PART: 04.038.295S, LOT NUMBER UNKNOWN, QUANTITY: ONE (1)) THIS REPORT IS FOR A 11MM/130 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE.THIS IS REPORT 1 OF 1 FOR PC-000176268.

  Patient problems: Failure of Implant

  MAUDE report 7508484 ↗

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-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-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-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