TFN-ADVANCE 04.038.290SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982098993), received between Apr 10, 2018 and Oct 7, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE HELICAL BLADE (NON-FENESTRATED) WAS SENT EVEN THOUGH A HELICAL BLADE (FENESTRATED) WAS ORDERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE 90MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594578 ↗
• InjuryMar 27, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE FRACTURE COLLAPSED AND THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) HELICAL BLADE CUT OUT THROUGH THE FEMORAL HEAD INTO THE JOINT. THE HELICAL BLADE WAS REMOVED AND NO FRAGMENTS GENERATED. THE NAIL REMAINED AND A SHORTER TFNA SCREW WAS IMPLANTED. ORIGINALLY, THE HARDWARE WAS IMPLANTED ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFUL. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN DISTAL LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8458316 ↗
• InjuryNov 20, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS REMOVED DUE TO CUT OUT OF THE HELICAL BLADE THROUGH THE SUPERIOR ASPECT OF THE FEMORAL HEAD AND REPLACED WITH HEMIARTHROPLASTY. THE TFNA WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. DURING AN APPOINTMENT, THE PATIENT COMPLAINED OF LEFT HIP PAIN AND IT WAS NOTED ON THE X-RAYS THAT THE IMPLANT HAD CUT OUT OF THE FEMORAL HEAD. THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: TFNA NAIL (PART: 04.037.142S, LOT: H496404, QUANTITY: 1), LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A TFNA HELICAL BLADE 90MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 8088632 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 TO REMOVE A TROCHANTERIC FEMORAL NAIL (TFN) ADVANCED SYSTEM SHORT NAIL AND A TFNA HELICAL BLADE. THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. SURGICAL OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR A TFNA HELICAL BLADE 90MM STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7838036 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A PROXIMAL FEMUR FRACTURE USING A TROCHANTERIC FIXATION NAIL - ADVANCE (TFNA) ON (B)(6) 2017. POSTOPERATIVELY, A NON-UNION WAS IDENTIFIED ON A ROUTINE FOLLOW-UP X-RAY. PATIENT WAS ASYMPTOMATIC (NO COMPLAINTS OF PAIN OR DISCOMFORT). THE PATIENT DID NOT HEAL DUE TO LATERAL CORTEX PORTION OF THE FEMUR BONE WAS MISSING BECAUSE OF THE COMPLEX FRACTURE PATTERN. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2018 AND RECEIVED A RIGHT TOTAL HIP REPLACEMENT. ALL THE REMOVED IMPLANTS WERE INTACT. THERE WERE NO ISSUES DURING THE REVISION AND NO SURGICAL TIME DELAY. THE PATIENT STATUS WAS STABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7440457 ↗
• InjuryApr 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) ON (B)(6) 2018 DUE TO FEMORAL HEAD CUTOUT AND NON-UNION. THE SURGEON WAS CONVERTING TO A TOTAL HIP. THE INITIAL SURGERY WAS APPROXIMATELY TWO YEARS AGO AND WAS DONE OUT OF STATE. DURING THE PROCEDURE THE SURGEON REMOVED ONE (1) 11MM/130 DEG TI CANN TFNA 170MM, ONE (1) TFNA HELICAL BLADE 90MM, AND AN UNKNOWN 5.0MM SCREW. THE IMPLANTS WERE REMOVED WITHOUT INCIDENT. THERE IS NO ADDITIONAL INFORMATION. CONCOMITANT DEVICE(S) REPORTED: CANNULATED NAIL (PART #: 04.037.142S, LOT #: H069675, QTY: 1). LOCKING SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

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

  MAUDE report 7412729 ↗

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-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-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