TFN-ADVANCE 04.038.190SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982098733), received between Jul 3, 2018 and Aug 26, 2025 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (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.

• MalfunctionAug 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PROXIMAL FEMUR FRACTURE WITH TFNA FENESTRATED SCREW. WHILE THE SURGEON WAS INSERTING THE TFNA FENESTRATED SCREW, THE GUIDE WIRE HAD NOT BEEN INSERTED, SO THE TFNA FENESTRATED SCREW WAS TEMPORARILY REMOVED. WHEN THE SURGEON CHECKED THE TFNA FENESTRATED SCREW THAT IT WAS CONFIRMED THAT THE OUTER EDGE OF IT HAD PEELED OFF IN THE FORM OF A WIRE. THE SURGEON DETERMINED THAT THE CONDITION WAS NOT NORMAL, AND A SPARE SCREW WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896032 ↗
• InjuryDec 11, 2023Break; Break

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE BETWEEN (B)(6) 2023, A BROKEN TFNA SCREW WAS DISCOVERED. THE PRODUCT WAS ORIGINALLY IMPLANTED ON (B)(6) 2023 AND EXPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18302474 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO OR FOR REMOVAL OF TFNA AND THA ON (B)(6) 2023. SURGEON VOICED IT WAS DUE TO ARTHRITIS AND MALUNION BUT NOT RELATED TO THE IMPLANT. THERE WERE PATIENT OUTCOME /CONSEQUENCES DUE TO MALUNION. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Arthritis; Malunion of Bone

  MAUDE report 17791657 ↗
• MalfunctionMay 15, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPLETE RADIOLUCENT INSERTION HANDLE BROKE WHILE IN THE PATIENT DURING SURGERY CAUSING THE NAIL TO ROTATE AND NOT ABLE TO DRILL FOR LAG SCREW OR PLACE LAG SCREW. THE SURGEON HAD TO TAKE OUT THE NAIL AND RESTART WITH A NEW HANDLE AND A NEW NAIL DUE TO INSERTION HANDLE MALFUNCTION. SURGERY WAS COMPLETED SUCCESSFULLY WITH SOME DELAY. THIS REPORT IS FOR AN UNK ¿ NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929406 ↗
• InjurySep 24, 2022Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP EVENT REMOVAL OF THE HARDWARE/EXPLANT WILL BE DONE DUE TO FAILURE. 90 Y/O IT FRACTURE HAD A TFNA IMPLANTED BY SURGEON ABOUT A MONTH AGO. LAG SCREW FAILED AND PENETRATED THE ACETABULUM. WE STARTED USING THE STATIC TORQUE LIMITING SET SCREWDRIVER A FEW MONTHS AGO TO CONFIRM SET SCREW IS SEATED, BUT THIS ISSUE STILL OCCURRED. IT IS UNKNOWN IF THE FAILURE WAS DUE TO BONE QUALITY, TECHNIQUE, OR IMPLANT FAILURE. THE IMPLANT WILL BE REMOVED TOMORROW ((B)(6) 2022. PATIENT WAS EXPERIENCED POST-OP MALFUNCTION WHICH IS LAG SCREW MEDIALIZED AND CUTOUT INTO THE ACETABULUM. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15480596 ↗
• MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2022 ON AN UNKNOWN DATE, THE LAG SCREW THREADS WERE STRIPPING OFF AS IT WAS INSERTED IT INTO THE FEMORAL HEAD. NO PATIENT CONSEQUENCE WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402942 ↗
• InjuryAug 26, 2022Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR WITH THE TFNA LONG IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. A REVISION SURGERY WAS PLANNED FOR (B)(6) 2022, THE TFNA LONG IMPLANTS WILL BE REMOVED AND REPLACED WITH BHA. THE DETAILS OF THE DEFECT ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED SCREW 90MM ¿ STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15302542 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 2 OF 15 FOR COMPLAINT (B)(4).

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

  MAUDE report 12088343 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PAIN. TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) SCREW, TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) FEMORAL NAIL AND TITANIUM LOCKING SCREW WERE REMOVED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM - STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12071381 ↗
• MalfunctionApr 8, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA ) CONVERSION TO TOTAL HIP. TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WAS REMOVED DUE TO CUT OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM - STERILE THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633923 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, A REVISION SURGERY OCCURRED FOR REMOVAL OF HARDWARE DUE TO NONUNION. THE ORIGINAL DATE OF IMPLANTATION WAS ON (B)(6) 2020. THE PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10677454 ↗
• InjuryApr 22, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) LAG SCREW WAS BROKEN DUE TO MAL-UNION. IT WAS IMPLANTED ON (B)(6) OF 2019. REVISION TO TOTAL HIP REPLACEMENT COMPLETED SUCCESSFULLY. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE AND BROKEN FRAGMENT OF TFNA (TROCHANTERIC FIXATION NAIL ADVANCED) LAG SCREW REMOVED WITH FEMORAL HEAD DURING EXCISION FOR TOTAL HIP REPLACEMENT. IT WAS REMOVED NORMALLY,WITH THE PROCESS FOR TFNA LAG SHAFT AS WELL AS TFNA TROCHANTERIC FIXATION NAIL ADVANCED NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOMES WAS COMPLETED. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) UNKNOWN SCREWS: LOCKING (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN), UNKNOWN END CAPS: TFNA (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; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9987790 ↗
• InjuryApr 2, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A FEMORAL NECK FRACTURE AND BROKEN FENESTRATED TFN ADVANCED SCREW AT FENESTRATION. THE BROKEN PIECE OF THE FENESTRATED TFN ADVANCED SCREW WAS NOT REMOVED. THE PATIENT WAS REVISED TO A 130 DEGREE BLADE PLATE. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS STABLE. CONCOMITANT PRODUCT: UNKNOWN TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); UNKNOWN SCREWS TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) TFNA FENESTRATED SCREW 90MM - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Foreign Body In Patient

  MAUDE report 8473989 ↗
• MalfunctionJul 3, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT FIXATION OF AN INTERTROCHANTERIC FRACTURE WITH A TITANIUM (TI) TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCE. THE WAS PATIENT WAS STABLE POST-OP. ON A FOLLOW-UP X-RAY, THE SURGEON NOTICED THAT THE FENESTRATED SCREW HAD COLLAPSED. THE SURGEON DECIDED TO CONTINUE TO OBSERVE THE PATIENT. NO REVISION IS PLANNED AT THIS TIME. CONCOMITANT DEVICE (S) REPORTED: 11MM/130 DEGREE TI CANNULATED TFNA 360MM/LEFT - STERILE (PART: 04.037.157S, LOT: H547670, QUANTITY: 1) 5.0MM TI LOCKING SCREW WITH T25 STARDRIVE 40MM F/IM NAIL - STERILE (PART: 04.005.530S, LOT: H601437, QUANTITY: 1) THIS REPORT IS FOR A TFNA FENESTRATED SCREW 90MM ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658571 ↗

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