TFN-ADVANCE 04.037.260SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982097408), received between Jan 5, 2018 and May 10, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT A TFNA (TROCHANTERIC FIXATION NAIL ADVANCED) NAIL ON (B)(6) 2023. POSTOPERATIVELY, THE NAIL BROKE AT THE COLUMN BLADE HOLE 4.5 MONTHS AFTER IMPLANTATION. THE NAIL WAS EXPLANTED ON AN UNKNOW DATE IN 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19287365 ↗
• InjuryNov 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A BROKEN TFNA IMPLANT. THE ORIGINAL PROCEDURE WAS DONE ON (REMOVED). THE ORIGINAL INJURY WAS A COMMINUTED INTERTROCHANTERIC AND SUBTROCHANTERIC FRACTURE RESULTING FROM A SLIP AND FALL. THE TFNA LOCKING DEVICE WAS LEFT ENGAGED. IT APPEARS THAT THE FRACTURE DID NOT HEAL PRIOR TO THE IMPLANT FAILING. NO INFORMATION IS CURRENTLY AVAILABLE AS TO WHETHER OR NOT THE PATIENT HAD ANOTHER FALL AND/OR ACCIDENT THAT MAY HAVE CAUSED THE IMPLANTS TO FAIL. THE BROKEN IMPLANTS WERE RECOVERED AND WILL BE SENT IN FOR ANALYSIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. THE REASON FOR REVISION SURGERY WAS A BROKEN IMPLANT. THIS REPORT IS FOR ONE (1) 12/130 DEG TI CANN TFNA 400/RIGHT-SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18150508 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WILL UNDERGO REMOVAL OF A BROKEN TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NEAR THE INSERTION POINT OF THE TFNA SCREW AND THAT THE PATIENT HAD A NONUNION. IT WAS ORIGINALLY IMPLANTED ON (B)(6), 2021. THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), TFNA END CAP (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN NAIL DISTAL LOCKING SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 12MM/130 DEG TI CANN TFNA 400MM/RIGHT-STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12715460 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION PROCEDURE FOR THE ADDITION OF A PLATE DUE TO A PROPAGATED FRACTURE RELATED TO AN IMPLANTED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. INITIALLY, ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES FOR A DISTAL 1/3 FEMUR FRACTURE AS THE PATIENT HAD A TOTAL KNEE PROSTHESIS (NON-SYNTHES) ON 2017 DISTAL TO THE ORIGINAL FRACTURE. DURING THE REVISION PROCEDURE A VARIABLE ANGLE (VA) CONDYLAR PLATE WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS WAS GOOD. THIS REPORT IS FOR ONE (1) 12MM/ 130 DEG TI CANN TFNA 400MM/ RIGHT-STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10087941 ↗
• MalfunctionApr 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INTRAMEDULLARY NAILING OF THE FEMUR ON (B)(6) 2019, A SURGICAL TECHNOLOGIST CONNECTED THE TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) TO INSERTION HANDLE AND IT CLICKED ON AND HAD A FIRM CONNECTION BY PULLING ON NAIL. HE THEN CHECKED THE TRAJECTORY BY INSERTING THE TROCHAR INTO THE INSERTION HANDLE. THE SURGEON INSERTED THE NAIL OVER THE BALL TIPPED GUIDE WIRE AND BEGAN ADJUSTING THE PLACEMENT OF THE NAIL WHEN THE NAIL DETACHED FROM THE INSERTION HANDLE. NAIL WAS SUCCESSFULLY REMOVED WITH AN EXTRACTION HOOK AND PUT A NEW NAIL IN USING A NEW CANNULATED CONNECTING SCREW. BOTH THE AFFECTED NAIL AND CONNECTING SCREW WERE TAGGED FOR PROCESSING. THERE WAS A TEN (10) MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE.  CONCOMITANT MEDICAL PRODUCTS REPORTED: GUIDE WIRE (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY # 1). INSERTION HANDLE (PART # UNKNOWN, LOT# UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) TFNA NAIL . THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8485128 ↗
• InjuryDec 4, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND OUT THAT A TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL BROKE AT THE JUNCTION OF THE HELICAL BLADE A FEW MONTHS AFTER A PATIENT HAD A HIP FRACTURE FIXED WITH TFNA. THE PATIENT REQUIRED A NAIL REMOVAL AND A TOTAL HIP ARTHROPLASTY. SURGICAL DELAY AND PROCEDURE OUTCOME IS UNKNOWN. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: TFN HELICAL BLADE (PART# 04.038.400, LOT# H557037, QUANTITY 1) UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: Failure of Implant

  MAUDE report 8130389 ↗
• InjuryApr 10, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE PATIENT'S 4TH MONTH POST-OPERATIVE CLINIC VISIT, X-RAYS CONFIRMED THAT THE IMPLANTED 12 MM SYNTHES TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) BROKE AT THE JUNCTURE OF THE NAIL AND THE LAG SCREW. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DEVICE ON AN UNKNOWN DATE IN (B)(6) 2017. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED DUE TO NON-UNION AND DELAYED HEALING, AND THE PATIENT WAS REVISED TO A 130 ANGLED BLADE PLATE. FRAGMENTS GENERATED FROM THE BROKEN DEVICE WERE EASILY REMOVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: TFNA SCREW 105 MM (PART # 04.038.105, LOT # 7939604, QTY: 1). UNKNOWN SYNTHES TFNA LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY: 1). UNKNOWN SYNTHES 5.0 MM DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY: 1). THIS REPORT IS FOR ONE (1) 12 MM/130 DEG TI CANN TFNA 400 MM/RIGHT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7413249 ↗
• MalfunctionJan 8, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE THE NAIL LOOSENED AND DISCONNECTED FROM THE CONNECTION SCREW. THE NAIL WAS INSERTED AND THE CONNECTING SCREW WAS LOCKED. THE INSERTION ARC WAS ADDED USING THE CONNECTION SCREW BUT WAS ONLY ABLE TO BE TURNED THREE TO FOUR TIMES. THE NAIL AND ARC HAD STRONG SIGNS OF MANIPULATIONS. ONCE THE NAIL WAS INSERTED AND AFTER REPEATEDLY HITTING, IT LOOSENED AND DISCONNECTED FROM THE CONNECTION SCREW AND COULD NOT BE RECONNECTED. THIS CREATED DIFFICULT NAIL PLACEMENT AND EXTEND SURGICAL TIME (EXACT EXTENSION IS UNKNOWN). THE NAIL WAS EXTRACTED WITH TRAUMA INSTRUMENTS IMPACTING THE NAIL IN ITS MOST PROXIMAL PART AND DAMAGING IT. CONCOMITANT DEVICES REPORTED: FLEXIBLE SCREWDRIVER D 5.0 (PART/LOT UNKNOWN, QUANTITY 1), TRAUMA INSTRUMENTS (PART/LOT UNKNOWN, QUANTITY UNKNOWN), SPIRAL LEAF HUNTER (PART/LOT UNKNOWN, QUANTITY 1), INSERTION BOW (PART/LOT UNKNOWN, QUANTITY 1). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7171758 ↗
• InjuryJan 5, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2017 DUE TO NON-UNION, BROKEN TFNA NAIL AND BROKEN TFNA DISTAL LOCKING SCREW. THE PATIENT IS REPORTED TO HAVE BEEN NON-COMPLIANT AND WALKED WITHOUT CANES OR CRUTCHES AS OPPOSED TO THE POST-OPERATIVE INSTRUCTIONS FOR THE FIRST THREE MONTHS AFTER THE INITIAL PROCEDURE THAT WAS CONDUCTED ABOUT SIX MONTHS PRIOR TO THE REVISION SURGERY. THE TFNA NAIL AND DISTAL LOCKING SCREW WERE OBSERVED TO BE BROKEN DURING A FOLLOW-UP X-RAY AFTER INITIAL SURGERY. NAIL WAS BROKEN JUST PROXIMAL TO THE LAG SCREW INSERTION HOLE. THE REMOVED HARDWARE INCLUDED ONE BROKEN TFNA NAIL, ONE INTACT LAG SCREW AND ONE BROKEN 5.0 MM DISTAL LOCKING SCREW. THE PATIENT WAS REVISED TO UNKNOWN QUANTITY OF 95-DEGREE CONDYLAR BLADE PLATES AND 4.5 MM CORTICAL SCREW CONSTRUCT ON THE PROXIMAL FEMUR. ALLOGRAFTS AND AUTOGRAFTS WERE USED TO TREAT THE NONUNION. THE LAG SCREW SITE WAS FILLED WITH NORIAN. DURING THE REVISION SURGERY, THE SURGEON USED A HELICAL BLADE COUPLING SCREW INTO THE DISTAL PORTION OF THE NAIL SO AS TO REMOVE THE DISTAL PART OF THE NAIL FROM THE PATIENT. DURING THE REMOVAL OF THIS PORTION OF THE NAIL, T

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7169255 ↗

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