TFN-ADVANCE 04.037.162SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982096708), received between Feb 8, 2018 and Oct 25, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT REPORTED THAT ON AN UNKNOWN DATE, THE TFNA SCREW BACKED OUT. THE PATIENT IS JUST OVER THREE (3) MONTHS POST OP FROM A COMPLEX RIGHT PROXIMAL FEMORAL FRACTURE WITH INTRACAPSULAR EXTENSION (NECK TO SUBTROCH REGION) FIXED ON (B)(6) 2022 WITH A LONG TFNA. THE PATIENT WAS PROGRESSING OK UNTIL ABOUT FOUR (4) WEEKS AGO WHEN HE HAD INCREASED PAIN AND COULD NOT WEIGHT BEAR. THE PATIENT¿S X-RAYS SHOW THAT THE TFNA LAG SCREW HAS BACKED OUT SIGNIFICANTLY. THE FRACTURE ITSELF HAS COLLAPSED A LITTLE AS TO BE EXPECTED BUT IS HEALING. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 WITH RIGHT LONG TFNA WITH CEMENT AUGMENTATION AND SMALL FRAGMENT PLATE. ON REMOVAL OF ORIGINAL TFNA, THE LAG SCREW WAS REMOVED WITHOUT ADJUSTING THE SET SCREW IN THE NAIL ¿ POST NAIL EXPLANATION THE LAG SCREW SLID IN CORRECT ORIENTATION WITHOUT OBSTRUCTION AND WHEN THE FLEXIBLE SET SCREWDRIVER WAS UTILIZED TO ADVANCE THE SET SCREW IT TURNED SEVERAL TIMES BEFORE ENGAGING. NOTICEABLE SCORING ON ANTERIOR SURFACE OF TFNA NAIL IN LINE WITH CENTER OF APERTURE FOR LAG SCREW. THIS REPORT INVOLVES ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STER

  Patient problems: Pain

  MAUDE report 15667782 ↗
• InjuryNov 25, 2020Break; Break

  IT WAS FURTHER REPORTED THE PATIENT WAS SUCCESSFULLY REVISED.

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

  MAUDE report 10905054 ↗
• InjuryMay 19, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BROKEN PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL WAS REMOVED AND A NEW ONE WAS REINSERTED. THE NAIL WAS CRACKED BUT WAS NOT COMPLETELY SEPARATED IN 2 PIECES. THE NAIL WAS ABLE TO FLEX AT THE POINT OF THE CRACK WHICH WAS AT THE BLADE HOLE OR NAIL JUNCTURE. THE NAIL WAS EASILY REMOVED. PATIENT WAS DOING GREAT DURING AND AFTER SURGERY. THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART NUMBER UNKNOWN; LOT UNKNOWN, QUANTITY: 1 ), SCREWS: LOCKING (PART NUMBER UNKNOWN; LOT UNKNOWN, QUANTITY: UNKNOWN), END CAPS: TFNA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY: 1). THIS REPORT INVOLVES 1 11MM/130 DEG TI CANN TFNA 420MM/RIGHT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10070695 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD RIGHT INTERTROCHANTERIC HIP NONUNION AND UNDERWENT A CONVERSION TO RIGHT TOTAL HIP ARTHROPLASTY WITH REMOVAL OF HARDWARE. THE SCREW FOUND WITHOUT DIFFICULTY AND THE DISTAL LOCKING SCREW REMOVED. THE PROXIMAL PORTION OF THE HIP DISLOCATED, AND THE PROXIMAL PORTION OF THE NAIL WAS OBTAINED AND THE UNKNOWN PLATE REMOVED. ORIGINAL IMPLANT DATE HAPPENED LAST (B)(6) 2018. PATIENT HAD A HIP FRACTURE APPROXIMATELY EIGHT TO TEN MONTHS AGO THAT WAS FIXED WITH INTRAMEDULLARY (IM) NAIL. PATIENT HAD WORSENING PAIN WHEN AMBULATING AS WELL AS DIFFICULTY WALKING, PAIN WAS QUITE SEVERE. PATIENT UNDERWENT PHYSICAL THERAPY AND HAD PAIN MEDICATIONS AND STILL HAVING DISCOMFORT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS WERE COMPLICATIONS WITH THE SURGICAL OUTCOME. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8588516 ↗
• InjuryOct 11, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) INTRAMEDULLARY NAIL WITH HELICAL BLADE ON FEMORAL HEAD DUE TO A BROKEN TFNA NAIL AND PAIN. THE TROCHANTERIC FIXATION NAIL ADVANCED WAS THEN REPLACED TO DYNAMIC HIP SCREW (DHS). ORIGINAL IMPLANT WAS IN (B)(6) 2018. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WAS REMOVED EASILY. THERE WAS A LESS DESIRABLE TREATMENT OUTCOME DUE TO RE-OPERATION WITH DELAYED HEALING AND DECREASED RANGE OF MOTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: TFNA HELICAL BLADE 115MM (PART# 04.038.315, LOT# UNKNOWN, QUANTITY 1); UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM/130 DEGREE TI CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7956892 ↗
• InjuryMay 11, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A FEMORAL FRACTURE PROCEDURE. DURING THE PROCEDURE, A HELICAL BLADE COMPLETELY MISSED THE NAIL. THERE WAS A SURGICAL DELAY OF ABOUT ONE AND A HALF HOUR TO GET THE NAIL OUT AND THE SURGEON HAD TO RE-DO THE PROCEDURE USING A SMALLER DIAMETER NAIL AND A NEW BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR ONE (1) 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7508651 ↗
• InjuryFeb 8, 2018Break; Break

  IT WAS FURTHER REPORTED THAT THE NAIL BROKE AT THE NAIL/SCREW JUNCTION WHICH MADE IT DIFFICULT TO REMOVE AS THERE ARE NO THREADS OR ANYTHING TO HOOK INTO. THEREFORE, THE SURGEON USED A BURR TO CREATE A HOLE FOR A HOOK TO FIT INTO THE NAIL TO REMOVE. THE LAG SCREW DID NOT BREAK AND THERE WAS NO MALFUNCTION ASSOCIATED WITH THE ORIGINAL LAG SCREW OR THE LAG SCREW USED IN THE REVISION SURGERY. THERE WAS APPROXIMATELY 30-45 MINUTES DELAY IN PROCEDURE. REVISION SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Code Available

  MAUDE report 7252382 ↗

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-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-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-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