TFN-ADVANCE 04.037.259SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982097392), received between Jul 11, 2018 and Oct 31, 2024 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , IMPLANTS WERE BROKEN. THE NAIL WAS BROKEN AT THE LAG SCREW INTERFACE. ALL FRAGMENTS WERE REMOVED. THE PATIENT WAS DIAGNOSED WITH NON-UNION, MAL-UNION AND THERE WAS HARDWARE REMOVAL AND REVISION OF FEMUR OF THE HIP. THE PATIENT OUTCOME WAS UNKNOWN.

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

  MAUDE report 20577886 ↗
• InjuryFeb 2, 2022Break; Break

  IT WAS REPORTED THAT ON DECEMBER 29, 2021, THE TFNA WAS BROKE AND THE SURGEON HAD TO REPLACED IT DOING A HEMI ARTHROPLASTY BY DEPUY. THE BLADE THAT WAS OUT OF THE LAG SCREW, CAME OUT OF THE FENESTRATED HELICAL LAG SCREW. THERE WERE TWO 5.0 DISTAL INNER LOCKING SCREWS THAT CAME OUT. CONCOMITANT DEVICES REPORTED: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNK - END CAPS: TFNA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2). TFNA FENESTRATED SCREW 110MM(PART# 04.038.210 , LOT# H735652, QUANTITY 1). THIS REPORT IS FOR ONE (1) 12/130 DEG TI CANN TFNA 380/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 13425347 ↗
• MalfunctionApr 29, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE ON (B)(6) 2021. THE SURGEON WAS SHOWN THE NAIL BEFORE OPENING THE STERILE PACKAGE. THE PACKAGE WAS OPENED, AND THE NAIL WAS INSERTED. AFTER LOOKING AT THE NAIL ON FLUOROSCOPY, THE SURGEON REALIZED THE NAIL WAS INCORRECT AND BACKED THE NAIL OUT. THE CORRECT NAIL WAS THEN INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FIVE (5) MINUTES. THIS REPORT IS FOR A 12MM/130 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744605 ↗
• InjuryMar 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 FOLLOW UP X-RAYS SHOWED THAT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) HELICAL BLADE HAD CUT THROUGH THE ACETABULUM AND ENTERED THE PELVIS. THE BLADE APPEARED FREE IN ROTATION ON THE POST OP X-RAYS; AN ANGIO CT WAS PREFORMED AND NO VESSEL DAMAGE WAS NOTED. THE TFNA WAS REMOVED AND THE HELICAL BLADE WAS EXTRACTED ON (B)(6) 2021. THE LOCKING MECHANISM WAS NOT ENGAGED AND DURING THE REMOVAL OF THE NAIL, THE HELICAL BLADE WAS FREE IN ROTATION. THE REVISION OPERATION WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: UNK - SCREW: (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 11447309 ↗
• InjuryJan 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CASE, WHILE PUTTING IN THE GUIDE WIRE INTO THE NECK AND HEAD OF THE FEMUR, SURGEON MISSED THE BLADE HOLE IN THE NAIL. SURGEON DRILLED FOR THE BLADE INTO THE HEAD AND INSERTED THE BLADE. WHEN LATERAL X-RAYS WAS TAKEN THEN IT WAS NOTICED THAT NAIL WAS MISSED AND THE BLADE WAS NOT THROUGH IT. SURGEON WAS ABLE TO REMOVE THE BLADE FROM THE HEAD AND THE NAIL FROM THE FEMUR WITHOUT INCIDENT. SURGEON THEN INSERTED A NEW NAIL AND INSERTED ANOTHER GUIDE WIRE THROUGH THE NAIL AND ULTIMATELY IMPLANTED THE HELICAL BLADE THROUGH THE HOLE AND INTO THE HEAD. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: GUIDE WIRE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), HELICAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR 1 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 11195655 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL BROKE. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: TFNA FENESTRATED HELICAL BLADE 95 MM, STERILE (PART# 04.038.395, LOT# 36P4782, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765464 ↗
• InjuryJun 24, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM LONG NAIL BROKE. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICES: UNK - SCREWS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), TFNA FENESTRATED HELICAL BLADE (PART: 04.038.400; LOT: UNKNOWN; QUANTITY: (B)(4)). THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10189889 ↗
• MalfunctionApr 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AND THE SCREW APPARENTLY NOT RAISED WHEN INSERTING THE LAG SCREW NORMALLY. THE NAIL AND THE LAG SCREW WERE DAMAGED, THEY WERE TRYING TO FIGURE OUT WHY IT WAS NOT WORKING. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED WITH OTHER IMPLANTS OF THE SAME SIZE. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 12MM/ 130 DEG TI CANN TFNA 380MM/ LEFT-STERILE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991894 ↗
• InjuryMar 30, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY DUE TO ADVERSE EVENTS. ON (B)(6) 2020, THE PATIENT PRESENTED TO THE SURGEON WITH PAIN AND WAS FOUND TO HAVE A NONUNION OF THE FRACTURE SITE AND MECHANICAL FATIGUE OF THE LOCKING SCREW AND A TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL. THE TFNA HELICAL BLADE, NAIL, AND THE LATERAL SEGMENT OF THE LOCKING SCREW WERE REMOVED. NO ATTEMPT WAS MADE TO RETRIEVE THE MEDIAL SEGMENT OF THE LOCKING SCREW. THE NON-UNION SITE WAS DEBRIDED AND A CANNULATED TROCHANTERIC FIXATION NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. THE DATE OF THE ORIGINAL IMPLANT WAS ON (B)(6) 2019, FOR A PROXIMAL FEMUR FRACTURE. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STER (PART # 04.005.530S, LOT # H218356. QUANTITY 1), TFNA FENESTRATED HELICAL BLADE 100MM - STERILE (PART # 04.038.400S, LOT # UNKNOWN. QUANTITY 1), THIS REPORT IS FOR ONE (1) 12MM/ 130 DEG TI CANN TFNA 380MM/ LEFT-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9897969 ↗
• InjuryNov 27, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN LEFT TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL. THE TFNA WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. BEGINNING ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN. ON (B)(6) 2018, PATIENT FELL AS A RESULT OF THE PAIN, AND PRESENTED TO THE EMERGENCY ROOM THE FOLLOWING DAY. THE BROKEN NAIL WAS DISCOVERED VIA X-RAY. ONE SMALL FRAGMENT OF THE NAIL WAS LEFT IN THE PATIENT, BUT THE REMAINING PIECES WERE REMOVED. DISTAL NAIL WAS REMOVED WITH RE-OPENING OF DISTAL FEMUR AND PUSHED OUT TOP OF FEMUR. CURRENT PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA SCREW 95MM (PART: 04.038.095S, LOT: H406589, QUANTITY: 1), 5.0MM TITANIUM (TI) LOCKING SCREW 48MM (PART: 04.005.538, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8106149 ↗
• InjurySep 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL PROCEDURE ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL AND HELICAL BLADE ON AN UNKNOWN DATE. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL BROKE OR SNAPPED AT THE JUNCTION OF THE HELICAL BLADE OR BUMP CUT IN THE NAIL. THE NAIL WAS REMOVED ALONG WITH THE BLADE AND THE PATIENT'S FEMUR WAS THEN PLATED USING THE LOCKING COMPRESSION PLATE (LCP) PROXIMAL FEMUR PLATE. PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), TFNA HELICAL BLADE (PART# 04.038.290S, LOT # UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available; Not Applicable

  MAUDE report 7882992 ↗
• 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 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7677625 ↗

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-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-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