TFN-ADVANCE 04.037.012SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982095701), received between May 2, 2018 and May 26, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6), 2026, CONNECTING SCREW FOR 125° TFNA AIMING ARM CRACKED WHILE INSERTING A NAIL. THIS CAUSED THE GUIDE TO BECOME LOOSE, SUBSEQUENTLY CAUSING THE GUIDE WIRE TO MISS THE NAIL. WHEN REAMING FOR A LAG SCREW, THE NAIL WAS DAMAGED DUE TO THE MISS PLACED GUIDE WIRE. THE NAIL HAD TO BE REMOVED AND REPLACED WITH A NEW ONE TO FINISH THE PROCEDURE. THERE WAS 30 MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276079 ↗
• InjuryOct 23, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF FOR TROCHANTERIC FEMORAL FRACTURE WITH THE BLADE. WHEN INSERTING THE BLADE GUIDE PIN, THE SURGEON CHECKED ITS POSITION FROM THE FRONT AND SIDE. THE SURGEON INSERTED THE GUIDE PIN FROM THE SIDE UNTIL IT CROSSED THE FRACTURE LINE. AFTER RETURNING THE FLUOROSCOPY TO THE FRONT, THE SURGEON INSERTED THE GUIDE PIN AGAIN JUST BEFORE THE SUBCHONDRAL BONE. AFTER MEASURING THE BLADE LENGTH, THE SURGEON PERFORMED LATERAL CORTICAL DRILLING AND BLADE INSERTION. AFTER LOWERING THE LOCKING MECHANISM, THE SURGEON ADDED COMPRESSION. THE SURGEON CHECKED THE FLUOROSCOPY FROM THE SIDE TO DETERMINE THE AMOUNT OF COMPRESSION AND FOUND THAT THE BLADE HAD DEVIATED SIGNIFICANTLY FURTHER THAN THE FIRST GUIDE PIN PLACEMENT, CAUSING PERFORATION OF THE FEMORAL HEAD. THE SURGEON HAD TO LOOSEN THE LOCKING MECHANISM SEVERAL TIMES AND THEN REMOVE THE BLADE BY REPEATEDLY BACKSLIDING. AFTER REMOVING THE NAIL, THE SURGEON CONFIRMED THAT THE LOCKING MECHANISM WAS RATTLING UP AND DOWN, AND THAT EVEN AFTER LOOSENING IT, IT WOULD IMMEDIATELY FALL BACK DOWN. THE WING OF THE SET SCREW WAS ALSO BROKEN AND STILL INSIDE THE PATIENT BUT WAS ABLE TO BE REMOVED U

  Patient problems: Bone Notching

  MAUDE report 23368633 ↗
• MalfunctionAug 5, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR TROCHANTERIC FRACTURE WITH THE NAIL AND THE BLADE. AFTER THE SURGEON INSERTED THE BLADE AND INJECTED CEMENT, HE WAS ABOUT TO INSERT THE LATERAL LOCKING SCREW WHEN HE NOTICED THAT THE AIMING ARM AND INSERTION HANDLE WERE LOOSE. JUST TO BE SURE, THE SURGEON CHECKED THE BLADE AND FOUND THAT IT HAD NOT PASSED THROUGH THE NAIL. THE SURGEON REMOVED THEM, CHANGED THE NAIL FROM F10MM TO F9MM, AND THE BLADE FROM 75MM TO 80MM, AND INSERTED AGAIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON GAVE THE FOLLOWING COMMENTS ABOUT THE CAUSE: 1) THE DEVICE WAS LOOSE, AND 2) WHEN INSERTING THE GUIDE WIRE TO POSITION THE BLADE, THE SURGEON LIFTED THE REDUCTION TOOL WITH FORCE, WHICH PUT STRESS ON THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719970 ↗
• MalfunctionMay 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A TROCHANTERIC FEMORAL FRACTURE. THE SURGEON PERFORMED THE SURGERY ACCORDING TO THE SURGICAL TECHNIQUE. BECAUSE A GAP WAS FOUND BETWEEN THE BONE FRAGMENTS, THE SURGEON COMPRESSED THE BONE FRAGMENTS USING A COMPRESSION DEVICE AND THEN TIGHTENED THE LOCKING MECHANISM. AT THAT TIME, THE LAG SCREW INSERTER WAS ALIGNED PARALLEL TO THE NAIL, BUT THE LOCKING MECHANISM DID NOT COME DOWN COMPLETELY AND THE PROPER FIXATION WAS NOT ACHIEVED. THE SURGEON TRIED AGAIN, BUT THE SITUATION DID NOT IMPROVE, SO THE SURGEON SUSPECTED THAT THE LOCKING MECHANISM WAS BROKEN AND REMOVED THE NAIL, WHICH CONFIRMED THAT THE LOCKING MECHANISM WAS BROKEN. THE SURGEON DETERMINED THAT REINSERTION OF THAT NAIL WAS NOT POSSIBLE AND INSERTED A DIFFERENT NEW NAIL OF A DIFFERENT DIAMETER. AFTER THAT, THE LOCKING MECHANISM WORKED PROPERLY, AND THE REST OF THE PROCEDURES WERE CARRIED OUT SUCCESSFULLY. THE CAUSE OF THIS EVENT WAS THOUGHT TO BE THAT THE INSERTER WAS NOT CORRECTLY ALIGNED PARALLEL TO THE NAIL, BUT SINCE NO SIGNIFICANT MISALIGNMENT WAS OBSERVED, THE SURGEON WAS SKEPTICAL AND PRESUMED IF IT WAS A MECHANICAL PROBLEM. THE SURGERY W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028156 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE WITH END CAP, TFNA SHORT NAIL AND BLADE. EVEN THOUGH THE BLADE WAS FULLY INSERTED, IT WAS ROTATED 90 DEGREES FROM NORMAL AND THE LOCKING MECHANISM DID NOT FUNCTION. THEREFORE, THE END CAP COULD NOT BE TIGHTENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 10MM/125 DEG TI CANN TFNA 170MM ¿ STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17985684 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL SURGERY DUE TO PAIN. THERE WAS NO BROKEN IMPLANT REPORTED. THE SURGEON THEN CONVERTED PATIENT TO A TOTAL HIP ARTHROPLASTY. REMOVED HARDWARE SUCCESSFULLY. PATIENT CONSEQUENCE UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 170MM - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 13481227 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, A NAIL WAS INSERTED INTO PATIENT DURING ORTHOPEDIC PROCEDURE; WHEN THE SURGEON TRIED TO LOCK DOWN THE LOCKING MECHANISM INSIDE THE NAIL TO THE LAG SCREW, IT WAS UNSUCCESSFUL. SURGEON TOOK THE NAIL OUT OF THE PATIENT AND THE INSERTION HANDLE BUT STILL COULD NOT MOVE THE LOCKING MECHANISM BECAUSE IT WAS JAMMED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES.  PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LAG SCREW (QUANTITY # 1), UNKNOWN INSERTION HANDLE (QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) 10MM/125 DEGREE TI CANNULATED TFNA 170MM - STERILE. THIS IS 1 OF 1 FOR REPORT (B)(4)..

  Patient problems: No Code Available

  MAUDE report 9203025 ↗
• InjuryAug 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF AN INTRAMEDULLARY NAIL AND SCREW FIXATOR BECAUSE OF INCREASING PAIN WITH FEELINGS OF LEG SHORTENING AS WELL AS A BROKEN LEFT INTERTROCHANTERIC FEMORAL NAIL. THE PORTION OF THE TROCHANTERIC FIXATION NAIL (TFNA) WAS REMOVED AS WELL AS THE PROXIMAL SCREW. THE DISTAL SCREW WAS BACKED UP TO ALLOW FOR PASSING OF THE EXTRACTION HOOK ONCE THIS HAS BEEN PASSED TO. THE NAIL WAS REMOVED AND THEN THE DISTAL PORTION OF THE NAIL WAS REMOVED WITHOUT ISSUE. ONCE THIS HAD BEEN ACCOMPLISHED AND ARTHROTOMY WAS MADE AS WELL AS REMOVAL OF HETEROTROPIC OSSIFICATION AROUND THE GREATER TROCHANTER TO FACILITATE REMOVAL OF THE NEXT SEGMENT ONCE THE NECK SEGMENT HAD BEEN REMOVED. ANOTHER STEM WAS IMPLANTED IN THE PATIENT. ON OR ABOUT (B)(6) 2018, THE PATIENT UNDERWENT INTRAMEDULLARY NAIL FIXATION OF THE LEFT INTERTROCHANTERIC FEMUR FRACTURE WITH CLOSED REDUCTION AND CASTING OF LEFT DISTAL RADIUS FRACTURE. PATIENT PRESENTED WITH A LEFT INTERTROCHANTERIC FEMUR FRACTURE WITH LEFT MULTISEGMENTAL DISTAL RADIUS FRACTURE. THIS REPORT IS FOR A 10MM/125 DEG TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Calcium Deposits/Calcification; Impaired Healing; No Code Available; Pain

  MAUDE report 8928213 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT WAS TAKEN TO SURGERY BECAUSE HE SUFFERED A FRACTURE OF THE MID SHAFT FEMUR DISTAL TO A SHORT TROCHANTERIC FIXATION NAIL ADVANCE (TFNA). THE SURGEON REMOVED THE SHORT TFNA AND REPLACED IT WITH A LONG TFNA. THERE WAS NO DELAY IN SURGERY; THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS STABLE. THERE IS NO ALLEGATION OR MALFUNCTION OF THE SHORT TFNA. CONCOMITANT DEVICE: TFNA HELICAL BLADE 105 MM (PART: 04.038.305, LOT: UNKNOWN, QUANTITY: 1), TRAUMA LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 10 MM/125 DEG TI CANN TFNA 170 MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7560808 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, TFNA SCREW, AND 5.0MM LOCKING SCREW ON UNKNOWN DATE IN 2017. ON UNKNOWN DATE IT WAS REVEALED THE TFNA SCREW HAD CUT THROUGH THE LATERAL CORTEX OF THE FEMUR AS A RESULT OF A NON-UNION. THE CUT THROUGH RESULTED IN IRRITATION OF SOFT TISSUE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT WAS REVISED TO A TOTAL HIP CONSTRUCT. THIS REPORT IS FOR ONE (1) 10MM 1215 DEGREE CANNULATED TFNA NAIL 170MM THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 7480843 ↗

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-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-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