TFN-ADVANCE 04.037.055SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982096111), received between Feb 6, 2019 and Oct 15, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548, 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.

• InjuryOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, WHILE INSERTING A TFNA NAIL, THE SURGEON PERFORATED THE FEMORAL NECK WITH THE HELICAL BLADE. THE NAIL AND HELICAL BLADE WERE EXTRACTED, AND REINSERTED. THE HELICAL BLADE WAS REPOSITIONED IN THE FEMORAL NECK AND THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING EXTRACTION, ONE OF THE PRONGS OF THE CONNECTION INTERFACE WAS SLIGHTLY BENT; HOWEVER THE NAIL WAS SUCCESSFULLY RECONNECTED AND INSERTED. THERE WAS A (15) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 10/130 DEG TI CANN TFNA 340/LEFT - SILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12639940 ↗
• 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) 10MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 11776725 ↗
• InjuryJan 15, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL DUE TO BREAKAGE AT THE PROXIMAL END WHERE THE HELICAL BLADE IS PLACED. THE NON-UNION OF THE FRACTURE WAS THE REASON THE HARDWARE IS BELIEVED TO HAVE FAILED. THE DATE OF THE INITIAL IMPLANT WAS SIX (6) MONTHS PRIOR. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICES: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN TFNA END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE 10 MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9591055 ↗
• InjuryFeb 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) NAIL, THE SURGEON TRIED TO COMPRESS THE HELICAL BLADE BUT THERE WAS A BACK OUT. THE SURGEON DECIDED NOT TO COMPRESS THE BLADE, BUT RATHER LOCKED THE BLADE INSTEAD. THIS ALLOWED THE BLADE TO SLIDE AS NORMAL (GUIDED COLLAPSE). IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310134 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, 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
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima