TFN-ADVANCE 04.038.085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982098450), received between Mar 14, 2018 and Jul 8, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THEY REMOVED A TFNA SHORT NAIL OUT OF A PATIENT. THE PATIENT WAS EXPERIENCING SOME SOFT TISSUE IRRITATION DUE TO BONY OVERGROWTH OVER THE NAIL OF THE PROXIMAL HEAD. A TFNA LAG SCREW WAS ALSO REMOVED. THE NAIL WAS ORIGINALLY PUT IN ON (B)(6) 2017. LABORATORY TESTS WERE TAKEN DUE TO CLINICAL FINDINGS AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THIS REPORT IS FOR ONE (1) TFNA SCREW 85MM - STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14957813 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT REMOVAL OF A SHORT TROCHANTERIC FEMORAL NAIL (TFNA) ON (B)(6) 2020. THE PATIENT SUSTAINED A DISTAL THIRD FEMUR FRACTURE. ALL IMPLANTS WERE SUCCESSFULLY EXPLANTED WITHOUT ISSUE AND THE PATIENT WAS REVISED WITH A (B)(6) NAIL. NO PATIENT CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS 2 OF 4 FOR REPORT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9824654 ↗
• InjuryAug 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE WHICH WAS AN INTRAMEDULLARY NAIL AND SCREW FIXATOR BECAUSE OF INCREASING PAIN WITH FEELINGS OF LEG SHORTENING AND HAD A BROKEN LEFT INTERTROCHANTERIC FEMORAL NAIL. ON (B)(6) 2018, THE PATIENT UNDERWENT INTRAMEDULLARY NAIL FIXATION OF LEFT INTERTROCHANTERIC FEMUR FRACTURE WITH CLOSED REDUCTION AND CASTING OF LEFT DISTAL RADIUS FRACTURE. SHE PRESENTED WITH A LEFT INTERTROCHANTERIC FEMUR FRACTURE WITH LEFT MULTISEGMENTAL DISTAL RADIUS FRACTURE. ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE. THE PORTION OF THE TROCHANTERIC FIXATION NAIL WAS REMOVED AS WELL AS THE PROXIMAL SCREW. THE DISTAL SCREW WAS BACKED UP TO ALLOW FOR PASSING OF THE EXTRACTION HOOK ONCE THIS HAS BEEN PASSED TO. THE NAIL WAS REMOVED AND THEN THE DISTAL PORTION OF THE NAIL WAS REMOVED WITHOUT ISSUE. ONCE THIS HAD BEEN ACCOMPLISHED AND ARTHROTOMY WAS MADE AS WELL AS REMOVAL OF HETEROTROPIC OSSIFICATION AROUND THE GREATER TROCHANTER TO FACILITATE REMOVAL OF THE NEXT SEGMENT ONCE THE NECK SEGMENT HAD BEEN REMOVED. ANOTHER STEM WAS IMPLANTED IN THE PATIENT. CONCOMITANT DEVICE REPORTED: 5.0MM TI LOCKING SCREW (PART# 04.005.524S; LOT

  Patient problems: Calcium Deposits/Calcification; Impaired Healing; No Code Available; Pain

  MAUDE report 8928230 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF ONE (1) TITANIUM CANNULATED TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL, ONE (1) TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SCREW, AND TWO (2) UNKNOWN 5MM LOCKING SCREWS DUE TO INFECTION AND PLACEMENT OF ANTIBIOTIC SPACER. THE DATE OF ORIGINAL IMPLANT WAS ON (B)(6) 2018. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8758239 ↗
• InjuryJan 16, 2019Break; Break

  01/16/2019. UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT THE CASE WAS COMPLETED ON (B)(6) 2017. THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) LAG SCREW AND UNKNOWN DISTAL LOCKING SCREW BROKE IN THE TFNA NAIL DURING AN UNKNOWN PROCEDURE. A PROPOSED REMOVAL PROCEDURE FOR A TOTAL HIP ARTHROPLASTY IS YET TO BE SCHEDULED. THERE WAS AN UNKNOWN SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVED THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TFNA SCREW 85MM - STERILE THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8254071 ↗
• MalfunctionNov 7, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE LAG SCREW IN A TROCHANTERIC FEMORAL NAIL-ADVANCE (TFNA) SYSTEM WAS DISCOVERED TO HAVE COLLAPSED. THE PATIENT INITIALLY UNDERWENT IMPLANTATION OF THE HARDWARE ON (B)(6) 2018. IT IS UNKNOWN IF A REVISION PROCEDURE WILL BE PERFORMED. CONCOMITANT DEVICES: TITANIUM (TI) CANNULATED TFNA NAIL (PART: 04.037.157S, LOT UNKNOWN, QUANTITY: 1), 5.0MM TI LOCKING SCREW 40MM (PART: 04.005.530S, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TFNA SCREW 85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8047671 ↗
• InjuryAug 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) PROCEDURE FOR A LEFT FEMUR SHAFT FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, THE FRACTURE WAS ANATOMICALLY REDUCED. SURGEON REAMED 1.5MM OVER THE DIAMETER OF THE NAIL. WHILE ATTEMPTING TO ROTATE THE NAIL WITHIN THE CANAL, SURGEON APPLIED HEAVY TORQUE TO THE AIMING ARM ATTACHED TO THE NAIL. WHEN THE LAG SCREW WAS DRILLED FOR AND IMPLANTED, THE LATERAL X-RAY CONFIRMED THE LAG SCREW WAS OUTSIDE THE NAIL. THE SCREW WAS REMOVED AND SURGEON REATTEMPTED TO TIGHTEN THE COUPLING SCREW BACK TO THE TOP OF THE NAIL TO THEN RE-INSERT THE LAG SCREW, BUT THE LAG SCREW STILL MISSED THE NAIL. SURGEON OPTED TO LEAVE THE LAG SCREW OUT AND USED TWO (2) DISTAL LOCKING SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10 MINUTES. THIS REPORT IS FOR ONE (1) TFNA SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7779474 ↗
• InjuryMar 14, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, PATIENT UNDERWENT AN IMPLANT PROCEDURE. ON AN UNKNOWN DATE POST-OPERATIVE, THE BLADE CUT THROUGH THE FEMORAL HEAD. ON (B)(6) 2018, PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) REMOVAL PROCEDURE DUE TO THE IMPLANT FAILURE. DURING THE PROCEDURE, ONE (1) STERILE TFNA SCREW 85 MM, AND ONE (1) STERILE 11 MM/130 DEGREE TI CANNULATED TFNA 360 MM/RIGHT WERE REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT OUTCOME REPORTED AS GOOD. CONCOMITANT DEVICE(S) REPORTED: PROXIMAL FEMORAL NAIL (PART# 04.037.156S, LOT# UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TFNA SCREW 85 MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7337819 ↗

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-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-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