TFN-ADVANCE 04.038.285SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982098979), received between Dec 1, 2017 and Jul 24, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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.

• InjuryJul 24, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, A HARDWARE REMOVAL OF ONE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL AND ONE (1) TFNA HELICAL BLADE WAS PERFORMED. THE SALES CONSULTANT NOTED THAT THE HELICAL BLADE DID NOT COLLAPSE AS IT TYPICALLY FUNCTIONED. THIS LED TO THE IMPINGING OF THE IMPLANT INTO THE RIGHT HIP OF THE PATIENT, REQUIRING A TOTAL HIP REPLACEMENT. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOMES WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: 10MM/130 DEG TI CANN TFNA340MM/RIGHT STERILE (PART NUMBER: 04.037.054S, LOT NUMBER: H407885, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 85MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7715625 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT ON (B)(6) 2018, DUE TO PAIN AND BREAST CANCER SPREADING TO THE PATIENT LEG. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL, TFNA HELICAL BLADE AND LOCKING SCREW ON AN UNKNOWN DATE A YEAR AGO. ALL IMPLANTS WERE REMOVED SUCCESSFULLY WITH NO ISSUES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS NOT REPORTED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7677635 ↗
• InjuryJun 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TROCHANTERIC FIXATION NAIL -ADVANCED (TFNA) ON (B)(6) 2018 DUE TO MIGRATION OF THE TFNA HELICAL BLADE. REPORTEDLY, THE SURGEON DID NOT THINK THE DEVICE FAILED BUT COULD POSSIBLY BE RELATED TO THE PATIENT¿S POOR BONE QUALITY. IT IS UNKNOWN IF THE PATIENT HAD DISCOMFORT RELATED TO THE DEVICE MALFUNCTION. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2018 AT WHICH TIME THE PATIENT WAS IMPLANTED WITH A TFNA NAIL, A TFNA HELICAL BLADE AND TWO LOCKING SCREWS. THE TFNA NAIL, TFNA HELICAL BLADE AND TWO LOCKING SCREWS WERE REMOVED WHOLE AND INTACT AND THE PATIENT WAS CONVERTED TO A TOTAL HIP PROTHESIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY REPORTED. NO HARM WAS REPORTED TO THE PATIENT. THE REPORTED PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA (PART 04.037.259S, LOT H423771, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 (PART 04.005.526S, LOT H567843, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 (PART 04.005.530S, LOT H601438, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7620088 ↗
• InjuryJan 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REMOVAL OF AN INTRAMEDULLARY (IM) TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO HELICAL BLADE CUT-OUT ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS (B)(6) 2017. THE PATIENT IS (B)(6) YEARS OLD, AND HAS POOR BONE QUALITY. THERE WAS NO REPORTED FALL OR OTHER TRAUMA. REMOVED HARDWARE INCLUDED: NAIL, BLADE AND LOCKING SCREW; ALL WERE INTACT. THE PATIENT IS IN HOSPICE AN WAS NON-AMBULATORY PRIOR TO THE REMOVAL PROCEDURE, SO NO HARDWARE REVISION WAS PERFORMED. THE ORIGINAL FRACTURE SITE COLLAPSED ON ITSELF. THE HARDWARE WAS REMOVED WITHOUT INCIDENT. NO SIGN OF INFECTION WAS PRESENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES: TFNA NAIL (PART 04.037.142S, LOT H310883, QUANTITY 1); LOCKING SCREW (PART 04.005.528, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7169478 ↗
• InjuryDec 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT HAD A SURGERY ON AN UNKNOWN DATE IN (B)(6) 2017 FOR INTER-TROCHANTERIC FRACTURE AND WAS TREATED WITH CEPHALO-MEDULLARY NAIL (TROCHANTERIC FIXATION NAIL, ADVANCED). SURGEON STATED THAT THE HELICAL BLADE WAS CUTTING OUT AND IT MAY BE DUE TO PATIENT FALLING A COUPLE TIMES RECENTLY. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION SURGERY AND WAS REVISED TO HEMIARTHROPLASTY OF THE HIP WITH DEPUY SYNTHES RECLAIM STEM MODULAR ENDO HEAD. ALL IMPLANTS THAT WERE INITIALLY PRESENT WITHIN THE PATIENT WERE EXPLANTED SUCCESSFULLY. THERE WAS NO REPORTED SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: 10MM/130 DEGREE TI CANN TFNA 360MM/LEFT ¿ STERILE (PART # 04.037.057S, LOT # H246312, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STERILE (PART # 04.005.524S, LOT # UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STERILE (PART # 04.005.528S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 85MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7076806 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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
• 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