TFN-ADVANCE 04.038.205Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982098788), received between Jun 26, 2018 and Oct 31, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, IMPLANTS WERE BROKEN. THE NAIL WAS BROKEN AT THE LAG SCREW INTERFACE. ALL FRAGMENTS WERE REMOVED. THE PATIENT WAS DIAGNOSED WITH NON-UNION, MAL-UNION AND THERE WAS HARDWARE REMOVAL AND REVISION OF FEMUR OF THE HIP. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 20577935 ↗
• InjuryAug 2, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, A TFNA WAS BEING REMOVED FROM THE PATIENT SO THAT A HIP REPLACEMENT COULD BE PERFORMED. THE TFNA WAS IMPLANTED APPROXIMATELY 6 MONTHS PRIOR. THE TFNA CONSTRUCT HAD FAILED AND THE NAIL WAS FOUND TO BE BROKEN WHERE THE CEPHALOMEDULLARY SCREW ENTERS THE NAIL. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 105MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17442804 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, INITIALLY SURGEON HAD A SHORT PROXIMAL FEMORAL NAILING SYSTEM (TFNA) PLACED DUE TO A FEMUR FRACTURE. THE PATIENT RETURNED TO THE HOSPITAL WITH A NEW FRACTURE, DISTAL TO THE IMPLANT. EXCHANGE NAILING WAS DONE WITH A LONG TFNA. PROCEDURE IS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 105MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11520135 ↗
• MalfunctionJun 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCREW INSERTER SPUN INSIDE THE TITANIUM PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED SCREW WITHOUT ADVANCING THE SCREW AND DAMAGING THE CONNECTION. THE SCREW WAS REMOVED WITH THE LAG SCREW EXTRACTOR AND A NEW SCREW WAS REPLACED WITH USING A NEW "T" HANDLE SCREW INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAILS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736952 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED FIXATION NAIL-ADVANCED (TFNA), TFNA FENESTRATED SCREW AND TWO (2) TITANIUM LOCKING SCREWS DUE TO PATIENT BROKE THE FEMUR BONE AGAIN. DEVICES WERE ORIGINALLY IMPLANTED ON AN UNKNOWN DATE. THERE WERE NO ALLEGATIONS AGAINST THE DEVICES YET THE SURGEON DECIDED TO CONVERT THE IMPLANTS TO A TOTAL HIP REPLACEMENT. ALL IMPLANTS WERE REMOVED EASILY AND INTACT WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

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

  MAUDE report 7639440 ↗

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