TFN-ADVANCE 04.038.090SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982098474), received between Feb 21, 2018 and Jul 3, 2023 — classified as 3 injuries, 2 malfunctions.

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); 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.

• MalfunctionJul 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2023, THE LIVE SCREW MISSED THE NAIL WHILE THE NAIL WAS PUT IN. SO, THEY HAD TO REMOVE IT AND REMOVE THE NAIL. IN REFERRING THE NEW NAIL AND OTHER OCCURRED LINED UP CORRECTLY. THIS REPORT IS FOR ONE (1) TFNA SCREW 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249904 ↗
• MalfunctionApr 22, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS PERFORMING A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AND THE SCREW APPARENTLY NOT RAISED WHEN INSERTING THE LAG SCREW NORMALLY. THE NAIL AND THE LAG SCREW WERE DAMAGED, THEY WERE TRYING TO FIGURE OUT WHY IT WAS NOT WORKING. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED WITH OTHER IMPLANTS OF THE SAME SIZE. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TFNA SCREW 90MM - STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988062 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT. REVISION SURGERY OCCURRED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9497565 ↗
• InjuryJun 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANTS FOLLOWED BY IRRIGATION AND DEBRIDEMENT ON (B)(6) 2018, DUE TO A NON-UNION AND CUT OUT OF LAG SCREW IN THE FEMORAL NECK. THE TFNA WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. DURING THE REMOVAL SURGERY, IT WAS DISCOVERED THAT THERE WAS A FEMORAL NECK FRACTURE, WHICH REQUIRED THE PATIENT TO BE SCHEDULED FOR A TOTAL HIP ARTHROPLASTY. ALL HARDWARE WAS REMOVED AND SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT PRODUCTS: TITANIUM LOCKING SCREW 42MM (PART: 04.005.532S, LOT: H539579, QUANTITY: 1), TITANIUM LOCKING SCREW 40MM (PART: 04.005.530S, LOT: H547561, QUANTITY: 1), TFNA LONG NAIL 10MM (PART: 04.037.059S, LOT: H487551, QUANTITY: 1). THIS REPORT IS FOR A TFNA SCREW 90MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7625253 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF ONE TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) NAIL, ONE (1) TFNA LAG SCREW AND ONE (1) TFNA DISTAL LOCKING SCREW ON (B)(6) 2018 DUE TO AN INFECTION. THE TFNA CONSTRUCT WAS INITIALLY IMPLANTED ABOUT TWO (2) YEARS BACK TO TREAT AN UNKNOWN TROCHANTERIC FRACTURE. THE FRACTURE WAS REPORTED TO HAVE HEALED SINCE; HOWEVER, THE PATIENT DEVELOPED AN INFECTION AT AN UNKNOWN TIME. THUS, THE SURGEON DECIDED TO REMOVE THE TFNA CONSTRUCT AND TREAT THE INFECTION USING AN UNKNOWN ANTIBIOTIC CEMENT. THE REMOVAL OF THE TFNA CONSTRUCT WAS CONDUCTED SUCCESSFULLY, WITH NO COMPLICATIONS TO THE PATIENT, EXCEPT HOWEVER, THE PACKAGING ON THE STERILE REAMING RODS SHEARING OFF ON ONE SIDE WHILE OPENING TWO (2) OF THESE REAMING RODS DURING THE REMOVAL SURGERY. THIS DID NOT DELAY THE SURGERY SINCE OTHER SETS WERE AVAILABLE AT THE TIME FOR USE. MULTIPLE X-RAYS WERE TAKEN DURING THE SURGERY, HOWEVER, NOT DUE TO THE REAMING RODS' PACKAGING SHEARING OFF. THE PATIENT WAS REPORTED TO BE STABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286193 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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
• 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-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-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