TFN-ADVANCE 04.038.390Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982099242), received between Jan 18, 2019 and Dec 1, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES. THE DEVICES WERE THEN REMOVED SEVERAL DAYS AFTER DUE TO FAILURE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18245447 ↗
• InjuryApr 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6)2023, THE SURGEON REMOVED TFNA NAIL, HELICAL BLADE AND 2 DISTAL SCREWS WITH NO ISSUES. EVERYTHING WAS REMOVED SUCCESSFULLY AND NAIL WAS NOT BROKEN. THE FEMUR FRACTURED AND THE SURGEON IMPLANTED A TOTAL HIP. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16748629 ↗
• InjuryDec 8, 2022Migration; Migration

  IT WAS REPORTED THAT A TFNA REMOVAL WAS TO BE PERFORMED ON (B)(6) 2022. THE HARDWARE WAS SUCCESSFULLY REMOVED. THE TFNA HELICAL BLADE HAD CUT OUT, AND IT WAS REMOVED AND REVISED WITH ANOTHER PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15939407 ↗
• InjuryOct 3, 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 REVISION SURGERY FOR A NON-UNION FEMORAL NECK FRACTURE. THE TFNA, BLADE, AND 5MM DISTAL INTERLOCK SCREW WERE REMOVED. ANOTHER NAIL WAS INSERTED. THERE WAS NO POST-OP DEVICE MALFUNCTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONEVTFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15531244 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022 THAT THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR A SUBTROCHANTERIC FEMUR FRACTURE IN (B)(6) 2022, TREATED WITH A TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW. THE FRACTURE WENT ON TO NON-UNION AND THE NAIL FRACTURED AT THE PROXIMAL HELICAL BLADE APERTURE. ON (B)(6) 2022, THE NAIL, HELICAL BLADE, AND SCREW WERE REMOVED WITHOUT INCIDENT. A NEW TFNA NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15410555 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A REVISION SURGERY OCCURRED FOR REMOVAL TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) CONSTRUCT. PATIENT WAS REVISED TO TOTAL HIP ARTHROPLASTY. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY. ORIGINAL IMPLANT DATE UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR A TFNA BLADE.

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

  MAUDE report 14465302 ↗
• InjurySep 9, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF HELICAL BLADE DUE TO IMPLANT CUTTING OUT OF FEMORAL HEAD. REMOVAL HAD NO INCIDENT AND LAG SCREW REPLACED THE IMPLANT. IMPLANT WAS DISCARDED BY FACILITY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (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 90MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 12448946 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, TFNA FENESTRATED HELICAL BLADE AND TITANIUM LOCKING SCREW DUE TO PAIN. THE SURGEON IMPLANTED A TOTAL HIP REPLACEMENT. SURGERY WAS SUCCESSFUL AND IMPLANTS WERE REMOVED WITH NO ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11778045 ↗
• InjuryDec 7, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL, TITANIUM HELICAL BLADE, AND A LOCKING SCREW DUE TO IMPROPER INSERTION OF TITANIUM HELICAL BLADE ON INITIAL SURGERY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 10958949 ↗
• InjuryMay 4, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN TROCHANTERIC FIXATION NAIL (TFN) NAIL AND HELICAL BLADE. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES ON DECEMBER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. SURGICAL OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFN END CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINTS INVOLVES 2 DEVICES. THIS REPORT IS FOR 1 TFNA FENESTRATED HELICAL BLADE 90MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10022149 ↗
• InjuryApr 29, 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 REMOVAL SURGERY OF THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE PATIENT WITH LONG TFNA FELL IN REHAB AND SUFFERED A DISPLACED DISTAL FEMUR FRACTURE. THE LONG NAIL WAS REPLACED WITH SHORT NAIL AND A VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL FEMUR PLATE WAS APPLIED DISTALLY. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 10011666 ↗
• InjuryJan 18, 2019Migration; Migration

  IT WAS REPORTED THAT ON AN (B)(6) 2018, A PATIENT UNDERWENT A HARDWARE REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DUE TO HELICAL BLADE BACKING OUT. THE SURGEON REMEMBERED THAT THE INTERLOCKING MECHANISM NOT FULLY ENGAGING WHEN HE PUT THE NAIL IN DURING INITIAL SURGERY. DATE OF ORIGINAL IMPLANT WAS (B)(6) 2018. PATIENT WAS REVISED TO HEMIARTHROPLASTY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT ADDRESSES THE POSTOPERATIVE ISSUE OF HELICAL BLADE BACK OUT AND THE RELATED COMPLAINT (B)(4) CAPTURES THE INTRA-OP EVENT DURING THE PRIMARY SURGERY ON (B)(6) 2018 WHERE A SCREWDRIVER WAS DIFFICULT TO REMOVE AND BROKE AT THE HANDLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 90MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8261606 ↗

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-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