TFN-ADVANCE 04.038.185SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982098719), received between Jan 22, 2021 and Dec 1, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ROUGHLY ONE YEAR AFTER IMPLANTATION, A TFNA LAG SCREW BROKE. THE PATIENT REQUIRED REMOVAL OF THE TFNA NAIL, LAG SCREW, AND DISTAL INTERLOCK SCREWS SO THAT THEY COULD HAVE A HEMI ARTHROPLASTY. THE REVISION WAS PERFORMED SUCCESSFULLY ON (B)(6) 2023. THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 85MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18248629 ↗
• MalfunctionMar 7, 2023Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ISSUE OCCURRED WHEN THE SURGEON WENT TO ADVANCE THE SET SCREW THAT IS PRELOADED IN THE PROXIMAL END OF THE NAIL. THE LAST COUPLE TURNS WITH THE SCREWDRIVER WHILE ENGAGED WITH THE SET SCREW WOULD NOT ADVANCE THE SCREW OVER THE PROXIMAL LOCKING SCREW. THE SURGEON FELT THE SET SCREW MIGHT BE CROSS THREADED. THEY BACKED THE SCREW PROXIMALLY THREE TIMES TO TRY AND ALIGN IT PROPERLY WITH THE INTERNAL THREADS. FINALLY, THE SET SCREW WAS ADVANCED FAR ENOUGH SO IT WAS LOCKED IN THE STATIC POSITION. THE SURGEON KNEW THE SET SCREW HAD NOT ADVANCED FAR ENOUGH FOR STATIC LOCKING BECAUSE THE PROXIMAL SCREW THROUGH THE NAIL WOULD STILL ROTATE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 85MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497217 ↗
• InjuryJul 29, 2022Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON AN UNKNOWN DATE DUE TO A BROKEN TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED LAG SCREW. ALL HARDWARE WAS REMOVED, AND THE PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 85MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15133908 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE TFNA IMPLANTS IN QUESTION. THE PATIENT WAS REPORTED TO BE DOING WELL. THE PATIENT HAD A RECENT FALL AND EXPERIENCED PAIN. THE PATIENT EXPERIENCED DIFFICULTY WALKED AND PRESENTED TO THE HOSPITAL. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED THE FEMORAL HEAD TO BE BROKEN. THE SURGEON DECIDED TO REMOVE THE TFNA IMPLANT AND PROCEED WITH REPLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REPLACEMENT SURGERY. THE IMPLANT WAS REMOVED AND THE PATIENT WAS PLANNED FOR BIPOLAR/TOTAL HIP REPLACEMENT. HOWEVER, INFECTION WAS FOUND IN THE PATIENT AND THE REPLACEMENT PROCEDURE DID NOT PROCEED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM - STERILE. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12870590 ↗
• InjuryOct 14, 2021Migration; Migration

  IT WAS REPORTED THAT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) CONSTRUCT WAS SUCCESSFULLY REMOVED ON (B)(6) 2021 DUE TO LAG SCREW CUT OUT. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THAT THE LAG SCREW HAD COMPLETELY CUT OUT OF THE FEMORAL HEAD. THE SURGEON WHO IMPLANTED THE DEVICE ON (B)(6) 2021 SAID THAT THE FEMUR HAD FALLEN INTO VARUS COLLAPSE LEADING TO CUT OUT. PATIENT WAS REVISED TO A TOTAL HIP. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 12632934 ↗
• InjuryMay 12, 2021Migration; Migration

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A REVISION SURGERY OF TOTAL HIP, DUE TO THE TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) LAG SCREW CUT OUT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 11815401 ↗
• MalfunctionJan 22, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 WHILE DOING AN INTERMEDIATE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) THE TFNA SCREW BOUND UP IN THE TFNA NAIL DURING INSERTION AND COULDN'T BE ADVANCED ALL THE WAY. THE TFNA SCREW WAS REMOVED USING THE EXTRACTOR IN THE TFNA SET. THE NAIL WAS REMOVED AND A NEW NAIL AND SCREW WERE IMPLANTED. THE CASE WENT SMOOTHLY AFTER THE REMOVAL OF THE NAIL. A THREAD FROM THE SCREW WAS SEEN AND REMOVED. THE NAIL CAME OUT EASILY AS IT WAS STILL ATTACHED TO THE INSERTION HANDLE. THERE WAS A DELAY OF ABOUT FIVE (5) MINUTES TO REMOVE AND REINSERT THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - EXTRACTION INSTRUMENTS: TFNA/PFNA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 85MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214560 ↗

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