TFN-ADVANCE 04.038.180SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982098696), received between Jul 16, 2020 and Sep 11, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  DURING THE PROCEDURE AT THE TIME OF MOUNTING THE SCREW, THIS FAILS SINCE IT DOES NOT ENTER EASILY INTO THE SCREWDRIVER AND MUST BE DONE WITH FORCE AND WITH A LOT OF PRESSURE TO BE ABLE TO MOUNT IT, WHEN REMOVING THIS DOES NOT LEAVE EASILY. AFOREMENTIONED FINALLY WAS SOLVED WHEN THE OTHER REFERENCE WAS PASSED, THUS ENDING THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026763 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE. THE SURGEON WAS SUCCESSFULLY REMOVED THE TFNA HARDWARE WITH NO ADVERSE EVENT. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 80MM - STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

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

  MAUDE report 12355469 ↗
• InjuryAug 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON PERFORMED SURGERY ON A RIGHT REVERSE OBLIQUE SUBTROCHANTERIC FEMUR FRACTURE. THE SURGEON IMPLANTED A 125-DEGREE TFNA NAIL, 80MM TFNA LAG SCREW, AND TWO 5.0MM LOCKING SCREWS. THE SURGEON NOTICED THAT POST OP XRAY SHOWS THAT THE LAG SCREW APPEARS TO BE BROKEN AND ABOUT HALFWAY IN THE THREADED PORTION OF ONE OF THE FENESTRATED HOLES. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2019. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE (PART NUMBER 04.037.026S, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW 44MM- FOR IM NAILS-STERILE (PART NUMBER 458.944S, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS-STERILE (PART NUMBER 458.942S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED SCREW 80MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10459195 ↗
• InjuryJul 16, 2020Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THERE WAS A REMOVAL SURGERY FOR THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA). THE TFNA DEVICE AS IMPLANTED ON OCTOBER 10, 2019. ON AN UNKNOWN DATE, THE NECK OF THE FEMUR COLLAPSED WHICH LEFT THE FEMORAL HEAD IMPACTED THROUGH THE INTERTROCHANTERIC LINE. THE FENESTRATED SCREW ELEMENT WAS NOT PROTRUDING OUTSIDE OF THE LATERAL CORTEX ENOUGH TO INDICATE A LOCKING MECHANISM FAILURE. THE MEDIAL TIP OF THE HEAD ELEMENT MAINTAINED ITS POSITION AT LEAST 10MM AWAY FROM THE CAPSULE OF THE HEAD, SO IT DID NOT CUT THROUGH. WHAT ULTIMATELY WAS THE CAUSE, WAS PROBABLY OSTEOPOROTIC BONE FAILING IN THE NECK, CAUSING ITS COLLAPSE. THE PATIENT UNDERWENT A CONVERSION TO A TOTAL HIP REPLACEMENT AFTER IMPLANT REMOVAL. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE CONCOMITANT DEVICES REPORTED: 10MM/125 DEGREE TI CANNULATED TFNA 360MM/RIGHT- STERILE (PART # 04.037.026S, LOT # 13L0998, QUANTITY 1); LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED SCREW 80MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10284021 ↗

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