TFN-ADVANCE 04.037.130SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982096449), received between Oct 17, 2018 and Aug 19, 2020 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR WHILE INSERTING THE UNKNOWN HELICAL BLADE FOR THE TROCHANTERIC FEMOATAL NAIL ADVANCED (TFNA) SYSTEM, THE UNKNOWN BLADE MISSED THE TFNA NAIL. THE SURGEON TOOK THE NAIL OUT AND STARTED OVER WITH A NEW UNKNOWN NAIL. THE SURGEON USED THE SAME UNKNOWN HELICAL BLADE AND THIS TIME IT WENT FINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TWENTY-FIVE (25) MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY). UNKNOWN HELICAL BLADE INSERTER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY). UNKNOWN SPIRAL COMBINATION HAMMER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10426792 ↗
• InjuryOct 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL AND NON-UNION. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION ON (B)(6) 2018. THE BREAKAGE OCCURRED IN THE PART WHERE AN UNKNOWN HELICAL BLADE INTERSECTS WITH THE NAIL. THE HELICAL BLADE WAS OBSERVED TO BE INTACT. THE HARDWARE WAS SUCCESSFULLY REMOVED AND WAS REPLACED WITH AN 8 HOLE RIGHT 4.5MM LCP PROXIMAL FEMUR PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY AND NO COMPLICATIONS. CONCOMITANT DEVICES: HELICAL BLADE (PART # 04.038.280S, LOT # H556771, QUANTITY 1), LOCKING SCREW (PART # 04.005.532, LOT # UNKNOWN, QUANTITY 1), LOCKING SCREW (PART # 04.005.534, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9194207 ↗
• InjuryOct 17, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT UNDERWENT REMOVAL OF THE TROCHANTERIC FIXATION NAIL ADVANCE (TFNA), THAT WAS ORIGINALLY INSERTED ON (B)(6) 2018. IT WAS IDENTIFIED POST-OPERATIVELY, ON AN UNKNOWN DATE, THAT THE TFNA LAG SCREW HAD NOT BEEN INSERTED THROUGH THE NAIL. THE LAG SCREW WAS ANTERIOR AND OUTSIDE OF THE NAIL. ON REMOVAL OF THE NAIL, IT WAS APPARENT THAT THERE WERE SCRATCHES ON THE OUTSIDE OF THE NAIL WHERE THE SCREW WAS PLACED, AND A SMALL SCRATCH ON THE INSIDE THROUGH THE SCREW HOLE. THERE WAS A PATIENT CONSEQUENCE REPORTED DUE TO FAILURE OF THE OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE. THE PATIENT UNDERWENT NAIL REMOVAL AND TOTAL HIP ARTHROPLASTY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS FOR A TITANIUM (TI) CANNULATED TFNA NAIL 400MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7974751 ↗

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-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-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-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