TFN-ADVANCE 04.037.058SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982096142), received between Nov 27, 2017 and Sep 6, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREW WAS NOT ENGAGING. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20163260 ↗
• InjuryNov 8, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE IMPLANTS FAILED AND THE PATIENT HAD TO UNDERGO REVISION SURGERY FOR PSEUDARTHROSIS AND RE-OSTEOSYNTHESIS . ONE (1) TFNA NAIL BROKE, ONE (1) TFNA LOCKING SCREW BROKE. THE TFNA WAS REPLACED WITH ANOTHER TFNA. THIS REPORT INVOLVES ONE (1) 10MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18092222 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY OF A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DUE TO A NON-UNION SITE IN TFNA ON (B)(6) 2021. THE HARDWARE WAS REMOVED WITHOUT ISSUE, THE NONUNION SITE WAS CLEANED OUT AND THE INTERMEDULLARY (IM) NAIL WAS REAMED, AND A LARGER TIBIAL ENTRY IMPLANT WAS IMPLANTED. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2021. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TROCHANTERIC FIXATION NAIL ADVANCED. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12862017 ↗
• 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 9497486 ↗
• MalfunctionDec 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DATE, A PATHOLOGICAL PATIENT HAD TO BE REOPERATED BECAUSE THE TITANIUM CANNULATED TFNA NAIL BROKE DUE TO THE GROWTH OF A TUMOR IN THE PATIENT. AT THE TIME OF REMOVAL (NAIL) THE EXTRACTOR GOT STUCK WITH A PIECE OF THE NAIL. THE PROCEDURE WAS COMPLETED BY A SECOND EXTRACTION INSTRUMENT. SURGERY WAS DELAYED BY TEN (10) TO FIFTEEN (15) MINUTES. PATIENT STATUS IS STABLE. CONCOMITANT DEVICES REPORTED: EXTRACTION INSTRUMENT FOR NAILS (PART # 03.037.032, LOT # 9769946, QUANTITY # 1). THIS (B)(4) CAPTURES THE INTRA-OP EVENT IN WHICH THE EXTRACTOR GOT STUCK WITH A PIECE OF THE NAIL AND (B)(4) CAPTURES THE POST-OP EVENT IN WHICH THE NAIL BROKE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9419469 ↗
• InjuryDec 5, 2019Break; Break

  DEVICE REPORT FROM SYNTHES, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 DATE, A PATHOLOGICAL PATIENT HAD TO BE REOPERATED BECAUSE THE TITANIUM CANNULATED TFNA NAIL BROKE DUE TO THE GROWTH OF A TUMOR IN THE PATIENT. NAIL FRAGMENTS WERE REMOVED WITHOUT ANY PROBLEM. THE NAIL WAS IMPLANTED ON (B)(6) 2019. PATIENT STATUS IS STABLE. CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART # 04.038.395, LOT # H677229, QUANTITY # 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), END CAP (PART # 04.038.000, LOT # 2L52596, QUANTITY # 1). THIS PC-(B)(4) CAPTURES THE POST-OP EVENT IN WHICH THE NAIL BROKE AND PC-(B)(4) CAPTURES THE INTRA-OP EVENT IN WHICH THE EXTRACTOR GOT STUCK WITH A PIECE OF THE NAIL. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 380 MM/RIGHT - STERILE THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9419148 ↗
• InjuryFeb 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT WAS IMPLANTED WITH A TFNA NAIL, FENESTRATED HELICAL BLADE AND DISTAL LOCKING SCREW FOR A REVERSE OBLIQUE TYPE INTERTROCHANTERIC FRACTURE. POST-OPERATIVE, ON (B)(6) 2019, PATIENT WAS PRESENTED TO THE SURGEON WITH NEW ONSET OF HIP PAIN. THE SURGEON REVIEWS THE X-RAYS AND OBSERVED A NON-UNION OF THE FRACTURE AS WELL AS A BROKEN TFNA AND DISTAL LOCKING SCREW. ON (B)(6) 2019, PATIENT UNDERWENT BONE GRAFTING, REVISION IM NAILING AND HARDWARE REMOVAL OF A BROKEN TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) AND DISTAL LOCKING SCREW. ALL BROKEN AND INTACT HARDWARE WERE REMOVED. A NEW TFNA, FENESTRATED HELICAL BLADE, TRAUMACEM AND TWO (2) LOCKING SCREWS WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE: FENESTRATED HELICAL BLADE (PART 04.038.395S, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8302551 ↗
• InjuryOct 24, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2017, PATIENT UNDERWENT PROCEDURE FOR ORTHOPEDIC HARDWARE FAILURE WITH A PERIPROSTHETIC FEMUR FRACTURE. POST-OPERATIVE, ON AN UNKNOWN DATE, THE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL ADVANCED ROD BROKE WHICH REQUIRES EXPLANTATION. IT WAS NOTED THAT THERE WAS HARDWARE FAILURE. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8001694 ↗
• InjuryJul 23, 2018Break; Break

  IT WAS REPORTED THAT PATIENT COMPLAINED OF HIP PAIN ON AN UNKNOWN DATE AND IT WAS DISCOVERED THE NAIL WAS BROKEN. THE TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. ON (B)(6) 2018, THE REVISION SURGERY WAS DONE DUE TO A BROKEN (TFNA ) NAIL, WHICH WAS REPORTED AS BROKEN THROUGH THE PROXIMAL HELICAL BLADE HOLE. IT WAS NOTED THE BROKEN NAIL DID NOT GENERATE ANY FRAGMENTS. THE NAIL WAS REMOVED AND REVISED WITH A LARGER (TFNA) NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN DISTAL LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); HELICAL BLADE (PART 04.038.310, LOT H512772, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7711729 ↗
• InjuryNov 27, 2017Break; Break

  CORRECTION TO CONCOMITANT DEVICES: TFNA HELICAL BLADE 90MM (PART 04.038.290, SERIAL/LOT (B)(4), QUANTITY 1); 5.0 TI LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 1).

  Patient problems: Failure of Implant

  MAUDE report 7059766 ↗

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-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