TFN-ADVANCE 04.038.205SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982098795), received between Nov 1, 2018 and Aug 21, 2024 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 ALL IMPLANTS WERE REMOVED DUE TO NONUNION, TRANSITIONED TO TOTAL HIP ARTHROPLASTY. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20017006 ↗
• MalfunctionJan 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE TFNA STEP DRILL AND SCREW BOUND ON THE TFNA NAIL. IT WAS BACKED OUT THE SET SCREW IN CASE IT HAD ADVANCED DOWN BUT THE SCREW STILL GOT STUCK IN THE NAIL. THEY THEN TOOK OUT THE SCREW AND NAIL AND OPENED NEW IMPLANTS FOR EACH AND IT WORKED FINE. SURGICAL DELAY UNKNOWN. PATIENT CONSEQUENCE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18534039 ↗
• MalfunctionAug 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2023 WHILE PUTTING THE SET SCREW DOWN IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), THE DRIVER SEEMED TO STOP PREMATURELY. IT WAS EXPLAINED TO THE SURGEON THAT THE SET SCREW MAY NOT BE DOWN BECAUSE THE LAG SCREW MAY BE ROTATED A LITTLE BIT, NOT ALLOWING SET SCREW TO GO DOWN. THE SURGEON KEPT MOVING FORWARD AND USED A TORQUE LIMITING DRIVER TO TORQUE DOWN AND ACCEPTED THE CONSTRUCT AS IS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432296 ↗
• MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023 WHILE PUTTING THE SET SCREW DOWN IN THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA), THE DRIVER SEEMED TO STOP PREMATURELY. IT WAS EXPLAINED TO THE SURGEON THAT THE SET SCREW MAY NOT BE DOWN BECAUSE THE LAG SCREW MAY BE ROTATED A LITTLE BIT, NOT ALLOWING SET SCREW TO GO DOWN. THE SURGEON KEPT MOVING FORWARD AND USED A TORQUE LIMITING DRIVER TO TORQUE DOWN AND ACCEPTED THE CONSTRUCT AS IS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427087 ↗
• InjuryAug 4, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE DRILLING WITH THE STEPPED DRILL, THE GUIDE PIN BOUND UP INSIDE OF THE DRILL BIT ON EXIT. WHILE TAPPING THE WIRE INSIDE, THE GUIDE PIN PERFORATED THE FEMORAL HEAD SIGNIFICANTLY INTO THE PELVIS. THE GUIDE PIN WAS REMOVED. THE LAG SCREW WAS THEN INSERTED AND WAS TOO LONG POSSIBLY PERFORATING THE FEMORAL HEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE 10 MINUTES SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED. 10/130 DEG TI CANN TFNA 170 - STERILE (PART # 04.037.042S, LOT# 231P163, QTY 1). UNK INSERTION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12274957 ↗
• InjuryMay 10, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY TO CONVERT A TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL RIGHT LONG "11MMX420MM WITH 105MM SCREW TO A SHORTER NAIL. DURING THE REVISION PROCEDURE, 420MM NAIL, SCREW AND DISTAL LOCKING SCREWS WERE REMOVED. DURING INSERTION OF THE NEW SCREW FOR THE NEW TFNA 380MMX12MM, THE SCREW WAS MEASURED AGAIN AT 105MM. SURGEON PLANNED TO USE SAME HOLE MADE BY PREVIOUS SCREW, THEREFORE LATERAL CORTEX OPENED, STEP REAMER AND TAP WAS DECLINED TO BE USED AS A PREVIOUS HOLE WAS NOTED TO EXIST. WHILE INSERTING THE SCREW SURGEON NOTED BONE WAS VERY DENSE AND SURGEON STRUGGLED TO ADVANCE THE SCREW. SURGEON ATTEMPTED TO BACK OUT SCREW TO REASSESS, HOWEVER DURING THIS EXTRACTION THE APPROXIMATELY 50% OF THE THREADS OF THE SCREW BROKE OFF. THE SURGEON WAS UNABLE TO REMOVE THE FRAGMENTS AND COMPLETED THE REVISION WITH A 90MM HELICAL BLADE. THERE WAS SURGICAL DELAY OF APPROXIMATELY TWENTY (20) MINUTES DUE TO AN ATTEMPT TO REMOVE THE SCREW FRAGMENTS. PATIENT CONSEQUENCES ARE UNKNOWN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCRE

  Patient problems: Foreign Body In Patient

  MAUDE report 11798600 ↗
• MalfunctionApr 14, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE PUTTING IN A TROCHANTERIC FIXATION NAIL ADVANCED(TFNA) FENESTRATED SCREW THE END OF THE SCREW DEFORMED DUE TO PATIENTS HARD BONE. THE SURGEON DID NOT TAKE THE SCREW OUT. THE SURGERY COMPLETED SUCCESSFULLY, AND PATIENT STATUS WAS OK. THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED SCREW 105MM  STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11665789 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 PATIENT UNDERWENT A HARDWARE REMOVAL AND TOTAL HIP SURGERY DUE TO NON-UNION. THE PATIENT HAD A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DONE IN (B)(6) 2020. THE PATIENT VOICED TO SURGEON THAT HIS PREVIOUS SURGEON STATED IT WAS A HARDWARE FAILURE AND THAT IS WHY HE FAILED TO HEAL. THE SURGEON DOING SURGERY ON (B)(6) 2021 STATED IT WAS NOT A HARDWARE FAILURE AND IT WAS BECAUSE OF HIS BONE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Tissue Injury

  MAUDE report 11475398 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A LAG SCREW IN NEED OF REPLACEMENT WITH A SHORT LAG SCREW. IT WAS FOUND THAT THE NAIL WAS BROKEN AT THE LEVEL OF THE LAG SCREW. THE NAIL WAS REMOVED AND THE NAIL, LAG SCREW AND LOCKING SCREW WERE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304496 ↗
• InjuryOct 28, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE THE SURGEON WAS INSERTING PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FENESTRATED LAG SCREW IT WAS DETERMINE THAT SHE HAD PERFORATED THE HEAD OF THE FEMUR AS PER X-RAYS RESULT. THE TFNA FENESTRATED LAG SCREW WAS REMOVED AND REPOSITIONED TO A MORE FAVORABLE PLACE IN THE FEMORAL HEAD AND NECK AND SURGERY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART# 04.037.042S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 105MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10750581 ↗
• MalfunctionJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  CONCOMITANT DEVICES:INSERTION INSTRUMENTS: TRAUMA (PART#UNKNOWN, LOT#UNKNOWN. QUANTITY 1), NAILS: TFNA (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10340536 ↗
• InjuryApr 22, 2019Migration; Migration

  THIS REPORT IS AGAINST MAUDE REPORT MW5084736, A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT MEDICAL DEVICES REPORTED: UNK - NAIL HEAD ELEM: RAFN SPIRAL BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1); UNK - SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 8537652 ↗
• InjuryMar 7, 2019Migration; Migration

  A NEW TFNA CONSTRUCT WAS IMPLANTED SUCCESSFULLY. (B)(4) CAPTURES THE SECOND LAG SCREW THAT WAS REMOVED AND (B)(4) CAPTURES THE FIRST LAG SCREW THAT WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 8400795 ↗
• MalfunctionNov 1, 2018Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  12/10/2018: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON OCTOBER 17, 2018, DURING AN UNKNOWN SURGERY A TROCHANTERIC FEMORAL NAIL ADVANCED FENESTRATED SCREW SEEMED MISALIGNED AND WAS DIFFICULT TO INSERT ON A SCREW INSERTER. DURING EXTRACTION, THE SCREW CAME OFF THE HANDLE AND THE THREADS OF THE SCREW WAS STRIPPED AND DEBRIS WAS LEFT IN THE PATIENT. THE SURGEON LEFT THE METAL THREADS IN THE PATIENT. IT WAS UNKNOWN IF WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027942 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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