TFN-ADVANCE 04.038.110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982098559), received between Jan 31, 2018 and Dec 17, 2018 — classified as 3 injuries.

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

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

• InjuryDec 17, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY OF A LAG SCREW AND A TITANIUM CANNULATED TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) SHORT NAIL. IT WAS A 110 MM SCREW THAT COLLAPSED LATERALLY. PATIENT REPORTED ISSUES OF PAIN AND IRRITATION AT THE SIDE OF THE HIP AND TISSUE AREA. THE SCREW WAS REMOVED, AND THE SHORTER 90 MM SCREW WAS PUT IN PLACE. AFTER THE SURGERY, THE SURGEON VIEWED THE X-RAY FROM THE ORIGINAL SURGERY AND REPORTED HE STATICALLY LOCKED THE LAG SCREW ON THE ORIGINAL SURGERY TO PREVENT GUIDED COLLAPSE DUE TO THE REVERSE OBLIQUE FRACTURE PATTERN. THE TFNA AND SCREW WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. THERE WAS NO DELAY IN THE REVISION SURGERY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: TITANIUM CANNULATED TFNA (PART# 04.037.142S, LOT# H171125, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA SCREW 110MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8171065 ↗
• InjuryMar 22, 2018Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO MIGRATION OF THE LAG SCREW. X-RAYS WERE PERFORMED ON (B)(6) 2018 AND IT WAS FOUND THAT THE TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LAG SCREW WAS FOUND PARTIALLY THREADED INTO PELVIC WALL, AND POTENTIALLY ADVANCED TO THE BLADDER. IT WAS NO LONGER ENGAGED TO THE NAIL. PATIENT HAD A CYSTOSCOPY LEFT, RETROGRADE PYELOGRAM AND LEFT URETHRAL STENT INSERTION. THE HARDWARE WAS REMOVED AND PATIENT WAS REVISED TO A HEMIARTHROPLASTY. SURGICAL DELAY AND PATIENT OUTCOME ARE UNKNOWN. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017. CONCOMITANT DEVICES REPORTED: 11MM/130 DEGREE TITANIUM CANNULATED TFNA 170MM- STERILE (PART # 04.037.142S, LOT # H447333, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. (B)(4).

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7363955 ↗
• InjuryJan 31, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKI ACCIDENT AND PRESENTED WITH A RIGHT FEMUR FRACTURE ON AN UNKNOWN DATE. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNDER THE INFLUENCE OF ALCOHOL AT THE TIME OF THE EVENT. ON (B)(6) 2018, AN ORIGINAL SURGERY TO TREAT TO FEMUR FRACTURE USING TROCHANTERIC NAIL FIXATION ADVANCED SYSTEM (TFN-A) WAS PERFORMED. PATIENT WAS IMPLANTED WITH ONE(1) TFN-A NAIL, (1) LAG SCREW, TWO (2) LOCKING SCREWS. THE INITIAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. ALL THE DEVICES WERE SUCCESSFULLY IMPLANTED AND THIS WAS CONFIRMED BY INTRA-OPERATIVE X-RAYS. DURING A FOLLOW UP VISIT ON AN UNKNOWN DATE, POST-OPERATIVE X-RAYS REVEALED THAT THE LAG SCREW WAS PROGRESSING/BACKING OUT FROM THE NAIL LATERALLY. PATIENT DID NOT EXPERIENCE PAIN NOR HAVE ANY OTHER ADVERSE EVENT. IT HAS NOT BEEN DECIDED YET IF THE PATIENT WILL UNDERGO REVISION SURGERY. CONCOMITANT DEVICES REPORTED: 10 MM/130 DEG TITANIUM CANNULATED TFNA 380 MM/RIGHT (PART NUMBER 04.037.058S, LOT NUMBER H190868, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA SCREW 110MM - STERILE. (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7230444 ↗

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-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-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