TFN-ADVANCE 04.038.405SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982099310), received between Aug 16, 2019 and Jun 2, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (8 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. How this data works · Data updated Oct 13, 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.

• InjuryJun 2, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSTOPERATIVE NAIL DISASSOCIATION/ MEDIALIZATION OF TFNA HELICAL BLADE AT A FOLLOW UP VISIT AFTER HIP SURGERY. REVISION SURGERY WAS REQUIRED. REVISION TOTAL HIP ARTHROPLASTY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 22124823 ↗
• InjuryJul 27, 2023Migration; Migration

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT UNDERWENT REVISION SURGERY ON JULY 17, 2023, DUE TO CUT THROUGH OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) BLADE. PATIENT WAS REVISED TO A HIP PROSTHESIS. THIS REPORT IS FOR AN UNKNOWN TFNA HELICAL BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17409811 ↗
• MalfunctionJun 14, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, SURGEON MANIFESTS A POOR CALIBRATION OF THE DIRECTIONAL ARM BECAUSE, WHEN MEASURING TO PLACE THE SPIRAL BLADE, IT GIVES US A LENGTH OF 105MM. THIS IMPLANT IS PASSED AND AT THE TIME OF DISMANTLING THE SCREWDRIVER, A ¿CUT OUT¿ OF THE BLADE OF MORE THAN 20MM IS EVIDENT. THE DR REQUESTS CHANGE OF THE SHEET OF 105MM FOR ONE OF 90MM. NO NEGATIVE IMPACT ON THE PATIENT. THIS REPORT IS FOR ONE (1) UNK - NAIL HEAD ELEMENTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126938 ↗
• InjuryMar 4, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MEETING OF THE AOTC HELD ON (B)(6) 2021, SLIDES WERE PRESENTED WHICH REPRESENTED FOUR TFNA CASES WITH MEDIAL BLADE MIGRATION INTO THE PELVIC AREA. ALL FOUR CASES WERE REVISED TO A PROSTHESIS. THIS CAPTURES THE CASE WITH PATIENT: FEMALE, (B)(6) YEARS OLD AT TIME OF EVENT. PATIENT BEGAN TO COMPLAIN OF PAIN ON (B)(6) 2021. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 105MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Pain

  MAUDE report 13667095 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA HELICAL BLADE, TFNA END CAP, AND LOCKING SCREW DUE TO THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AND NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 105MM - STERILE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11925496 ↗
• InjuryJul 29, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REMOVAL OF A PROTRUDING PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED HELICAL BLADE. IT WAS REVISED TO A SHORTER SCREW IMPLANT. THE PATIENT WAS OKAY. (B)(4) CAPTURES THE POST OP EVENT THE REMOVAL OF PROTRUDING PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED HELICAL BLADE AND (B)(4) CAPTURES THE INTRA OP EVENT WHEREIN DURING REVISION SURGERY THE SCREW INSERTER WAS NOT FUNCTIONING PROPERLY DUE TO DAMAGED THREADS. CONCOMITANT DEVICES REPORTED: UNKNOWN (TFNA) NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 TFNA FENESTRATED HELICAL BLADE 105MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10339949 ↗
• InjuryJul 22, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL THAT WAS BROKEN AFTER SIX (6) MONTHS OF IMPLANTATION. ORIGINALLY IMPLANTED WITH TFNA NAIL, TFNA BLADE AND UNKNOWN LOCKING SCREWS ON AN UNKNOWN DATE. THE FENESTRATED HELICAL BLADE WAS INTACT, THERE WAS INDENTATIONS ON THE BLADE DUE TO THE NAIL BREAKING AROUND IT. FRAGMENTS WERE COMPLETELY REMOVED. REMOVAL WAS DONE FAIRLY EASILY WITHOUT SIGNIFICANT INTERVENTION, THEN A TOTAL HIP ARTHROPLASTY WAS COMPLETED . THERE WAS PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 11MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10311324 ↗
• InjuryFeb 21, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) FENESTRATED HELICAL BLADE PROTRUDE - CEPHALOMEDULLARY. IT WAS IMPLANTED ON (B)(6) 2019. THERE WAS NO SCHEDULE FOR REVISION SURGERY, BUT IT IS POSSIBLE IN THE FUTURE THERE COULD BE A REVISION/ REMOVAL. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART # 04.037.063S, LOT # 9946743, QUANTITY # 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9740131 ↗
• InjuryNov 18, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DEVICES DUE TO CUTOUT.

  Patient problems: No Code Available

  MAUDE report 9336003 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 19, 2019, THE PATIENT UNDERWENT A REMOVAL OF TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) DUE TO A NON-UNION OF THE INTERTROCHANTERIC FEMUR FRACTURE. THE SURGEON SUCCESSFULLY REMOVED THE HARDWARE AND REPLACED THE DEVICE TO A DYNAMIC CONDYLAR SCREW (DCS) AND 95 DEG DCS PLATE 8 HOLE WITH AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE OF RIGHT FEMUR. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9044316 ↗
• InjuryAug 19, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE DISASSOCIATION OF AN UNKNOWN HELICAL BLADE FROM THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, THUS, THE BLADE MIGRATED MEDIALLY INTO THE PELVIS AND AN EXPLORATORY LAPAROTOMY WAS NEEDED TO RETRIEVE THE BLADE. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A TFNA SYSTEM ON (B)(6) 2019. THE PATIENT HAD A FALL ON AN UNKNOWN DATE AND REPORTED A ¿POP¿ AND SAW A SURGEON. AN X-RAY TAKEN ON (B)(6) 2019, CONFIRMED THE MIGRATION OF THE FENESTRATED HELICAL BLADE INTO THE PELVIS. DURING REVISION, ALL IMPLANTS WERE SUCCESSFULLY REMOVED. THE TFNA NAIL AND LOCKING SCREW WERE REMOVED FIRST. THE FENESTRATED HELICAL BLADE REMOVAL WAS UNSUCCESSFUL, CONSEQUENTLY, THE ABDOMINAL LAPAROTOMY WAS NECESSARY TO REMOVE IT FROM THE PELVIS AND INSPECT OTHER SURROUNDING TISSUES. THE PATIENT WAS REVISED TO A NEW IMPLANT. THERE WAS NO SURGERY DELAY. THE PATIENT IS IN STABLE CONDITION. THIS REPORT CAPTURES THE INTRA-OP EVENT WHEREIN THERE WAS AN UNSUCCESSFUL REMOVAL OF HELICAL BLADE WHEREIN AN ABDOMINAL LAPAROTOMY WAS DONE TO REMOVE THE BLADE FROM THE PELVIS WHILE (B)(4) CAPTURES THE POST-OP EVENT DUE TO DISASSOCIATION OF A HELI

  Patient problems: No Code Available

  MAUDE report 8907735 ↗
• InjuryAug 16, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE DISSOCIATION OF AN UNKNOWN HELICAL BLADE FROM THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, THUS, THE BLADE MIGRATED MEDIALLY INTO THE PELVIS AND AN EXPLORATORY LAPAROTOMY WAS NEEDED TO RETRIEVE THE BLADE. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A TFNA SYSTEM ON (B)(6) 2019. THE PATIENT HAD A FALL ON AN UNKNOWN DATE AND REPORTED A ¿POP¿ AND SAW A SURGEON. AN X-RAY TAKEN ON (B)(6) 2019, CONFIRMED THE MIGRATION OF THE FENESTRATED HELICAL BLADE INTO THE PELVIS. DURING REVISION, ALL IMPLANTS WERE SUCCESSFULLY REMOVED. THE TFNA NAIL AND LOCKING SCREW WERE REMOVED FIRST. THE FENESTRATED HELICAL BLADE REMOVAL WAS UNSUCCESSFUL, CONSEQUENTLY, THE ABDOMINAL LAPAROTOMY WAS NECESSARY TO REMOVE IT FROM THE PELVIS AND INSPECT OTHER SURROUNDING TISSUES. THE PATIENT WAS REVISED TO A NEW IMPLANT. THERE WAS NO SURGERY DELAY. THE PATIENT IS IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: TFNA NAIL ( PART # 04.037.242S, LOT # H807796, QUANTITY# 1); TFNA LOCKING SCREW ( PART # 04.005.528S, LOT # UNKNOWN, QUANTITY# 1). (B)(4) CAPTURES DISASSOCIATION OF A HELICAL BLADE FROM THE TROCHANTERIC FEMORAL NAIL ADV

  Patient problems: No Code Available

  MAUDE report 8902438 ↗

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