TFN-ADVANCE 04.038.380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982099211), received between Mar 1, 2022 and Feb 6, 2025 — classified as 8 injuries, 3 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY VIA TFNA FOR FRACTURE ON FEMUR WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, COSTOCLAVICULAR ROTATION DUE TO NECK FRACTURE WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED TO REMOVE TFNA AND REPLACE TO ARTIFICIAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 21322867 ↗
• MalfunctionNov 27, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR A FRACTURE OF THE BASE OF THE NECK OF THE LEFT FEMUR WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, AFTER BLADE INSERTION, AN ATTEMPT WAS MADE TO LOWER THE SET SCREW USING THE FLEXIBLE SCREWDRIVER IN QUESTION, BUT THE SCREWDRIVER HIT THE PELVIS AND COULD NOT BE INSERTED DEEP ENOUGH. THE AFFECTED SIDE WAS TURNED INWARD AND THE UPPER BODY WAS BENT, AND THE SET SCREW WAS LOWERED LITTLE BY LITTLE BY INSERTING AND ROTATING THE SCREWDRIVER WHILE LIGHTLY TAPPING THE HANDLE OF THE SCREWDRIVER WITH A HAMMER. DURING THIS TIME, THE SCREWDRIVER WAS RUBBING AGAINST THE SKIN, AND THE SURGEON PROCEEDED TO LOWER THE SET SCREW, ALTHOUGH HE WAS AWARE THAT THE SKIN WAS DAMAGED. FROM THE MIDDLE OF THE PROCESS, IT WAS CONDUCTED WITH A METAL PLATE BETWEEN THE DRIVER AND THE SKIN. ALTHOUGH THE SCREWDRIVER WAS BEING TURNED WHILE CHECKING THE POSITIONAL RELATIONSHIP BETWEEN THE CONVEXITY OF THE TIP OF THE DRIVER AND THE INSERTION HANDLE IN QUESTION THROUGH FLUOROSCOPY, THE SCREWDRIVER STOPPED TURNING AT A DISTANCE OF ABOUT 1 CM FROM THE CONVEXITY OF THE SCREWDRIVER TO THE INSERTION HANDLE, WHICH WAS USED AS AN INDICATOR. THE PROCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796724 ↗
• InjuryAug 22, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE ORIF WITH THE TFNA BLADE FOR FEMORAL TROCHANTERIC FRACTURE. AFTER SURGERY, CUT-OUT WAS CONFIRMED. THEREFORE, THE BLADE WILL BE REMOVED. THE CAUSE OF THE CUT-OUT IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 80MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20042759 ↗
• InjuryJul 10, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FEMORAL INTERTROCHANTERIC FRACTURE WITH TFNA LONG. AFTER THE SURGERY ON (B)(6) 2024, IT WAS CONFIRMED THAT THE BLADE IN QUESTION HAS REACHED THE CUT-THROUGH, AND THE SECOND SURGERY WAS PERFORMED. THE BLADE (80 MM) WAS REMOVED AND 75 MM BLADE WAS IMPLANTED. CEMENT AUGMENTATION WAS PERFORMED AT THE DISCRETION OF THE SURGEON AFTER FULLY EXPLAINING AND UNDERSTANDING THAT THE USE OF CEMENT IS CONTRAINDICATED IN CASES OF PERFORATED BONE HEADS. THE PROCEDURE WAS CAREFULLY PERFORMED TO AVOID CEMENT LEAKAGE FROM THE ARTICULAR SURFACE AND FROM THE FRACTURE SITE, AND 2 ML OF CEMENT WAS INJECTED. INTRAOPERATIVE IMAGING AND POSTOPERATIVE X-RAYS CONFIRMED THE ABSENCE OF CEMENT LEAKAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 80 - SILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19715543 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN TYPE OF INFECTION WAS CONFIRMED. THE INITIAL IMPLANTATION OCCURRED ON (B)(6) 2023. ON (B)(6) 2024, AN APPOINTMENT FOR A REMOVAL OF A TFNA IMPLANT WAS SCHEDULED. PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 80MM ¿ STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18841185 ↗
• InjuryNov 7, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT PRIMARY SURGERY WITH THE TFNA IN QUESTION FOR A FRACTURE. THE INTRAOPERATIVE ROTATION CONTROL OF THE REDUCTION WAS DIFFICULT, THE BLADE TIP WAS PROXIMAL IN THE FEMORAL HEAD. TWO WEEKS AFTER THE SURGERY THE BLADE WAS DISLOCATED PROXIMALLY. THE SURGEON DETERMINED THAT THE BLADE WOULD CUT OUT, SO A BHA WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 80MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18083014 ↗
• InjuryJun 2, 2023Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR WITH TFNA (TROCHANTERIC FIXATION NAIL ADVANCED) HELICAL BLADES AND TFNA SCREWS AND NAILS. A MIGRATION OF THE BLADE HAS OCCURRED AND REVISION SURGERY OCCURRED (B)(6) 2023. CONCOMITANT DEVICES: TFNA NAIL, PART# 04.037.015S, LOT# 783P667. UNKNOWN DISTAL SCREW, PART# UNK, LOT# UNK. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR (1) TFNA FENESTRATED HELICAL BLADE 80MM - STERILE.

  Patient problems: Failure of Implant

  MAUDE report 17050676 ↗
• MalfunctionFeb 27, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE TFNA NAIL AND THE BLADE FOR THE FEMORAL TROCHANTERIC FRACTURE. AFTER INSERTION OF THE NAIL, THE BLADE, THE AUGMENTATION, AND THE LOCKING SCREWS, THE IMAGE SHOWED THAT MEDIAL CORTEX OF FEMORAL DIAPHYSIS AND THE NAIL COVERED. IT WAS CONFIRMED THAT THE NAIL WAS NOT INSERTED INTO THE MEDULLARY CAVITY AND WAS LOOSENED BACKWARD. THE SURGEON REMOVED THE BLADE AND THE NAIL ONCE, THE NAIL WAS RE-INSERTED. HOWEVER, THE HOLLOW PART WAS STUCK WITH CEMENT AND THE GUIDE PIN COULD NOT BE INSERTED. THE SURGEON INSERTED A NEW 85 MM BLADE. AT FIRST, THE SURGEON SELECTED THE 80 MM BLADE FOR CEMENT INJECTION WHEN THE MEASUREMENT WAS 85 MM. THERE WAS STILL SPACE FOR THE FEMORAL HEAD, AND A LONGER BLADE WAS SELECTED. IF ALL 85 MM BLADE WAS INSERTED, THE DISTANCE BETWEEN THE BLADE TIP AND THE FEMORAL HEAD WOULD BECOME TOO SHORT. THEREFORE, THE BLADE WAS ADJUSTED ABOUT 3 MM BEFORE ALL 85 MM BLADE WAS INSERTED. THEN, THE LOCKING MECHANISM WAS TIGHTENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 10 MINUTES DELAY. THE SURGEON COMMENTED THAT THE GRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444284 ↗
• InjuryFeb 22, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE FEMORAL INTERTROCHANTERIC OSTEOSYNTHESIS FOR FEMORAL INTERTROCHANTERIC FRACTURE WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DURING A ROUTINE EXAMINATION ON (B)(6) 2023, IT WAS CONFIRMED THAT THE HEAD OF THE BONE HAD FALLEN OUTWARD TO THE POINT OF PERFORATION OF THE BLADE. THE REPLACEMENT TO BHA WILL BE PERFORMED ON (B)(6) 2023. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 80MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16420995 ↗
• MalfunctionJan 12, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON SAID THERE WAS AN ISSUE WITH THE TFNA HELICAL BLADE. SURGEON STATIC LOCKED THE HELICAL BLADE WITH TORQUE LIMITER. WHEN VIEWING THE POST OPERATIVE X-RAY ON (12-15-2022) THE SURGEON NOTICED THE HELICAL BLADE MIGRATED LATERAL. IMPLANT STILL IN PATIENT. NO PATIENT HARMS OR CONSEQUENCES HAVE BEEN REPORTED NOR ANY PLANS FOR REMOVAL OR SURGICAL INTERVENTION. NO ALLEGATION NOTED ON THE NAIL. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY# UNKNOWN). UNK - NAILS: TFNA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 80 - SILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146444 ↗
• InjuryMar 1, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE REMOVAL SURGERY OF THE TFNA AND THE TOTAL HIP ARTHROPLASTY BECAUSE OF CUT-OUT. THE TFNA WAS IMPLANTED ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 80 - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 13636925 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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