TFN-ADVANCE 04.038.400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982099280), received between Jun 14, 2019 and Nov 27, 2023 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON SEPTEMBER 26, 2023 THE SURGEON REMOVED A BROKEN TFNA DUE TO IMPLANT BREAKAGE. THE IMPLANT BROKE AT THE NAIL/BLADE JUNCTION. UPON INSPECTION OF THE RETURNED PRODUCTS ON NOVEMBER 21, 2023, IT WAS NOTED THAT THE HELICAL BLADE WAS WORN. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208558 ↗
• MalfunctionSep 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE DOING AN AO COURSE, TWO HELICAL BLADES GOT STUCK ON TWO HELICAL BLADE EXTRACTORS AFTER A SAW BONES LAB. THEY WERE REMOVED OUT OF THE SETS AND WILL BE REPLACED BY INSTRUMENT STAFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729738 ↗
• MalfunctionSep 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE DOING AN AO COURSE, TWO HELICAL BLADES GOT STUCK ON TWO HELICAL BLADE EXTRACTORS AFTER A SAW BONES LAB. THEY WERE REMOVED OUT OF THE SETS AND WILL BE REPLACED BY INSTRUMENT STAFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729734 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON REMOVED A TFNA CONSTRUCT FROM THE PATIENT BECAUSE OF SOFT TISSUE ISSUES AND PAIN. IT IS UNKNOWN IF THE HARDWARE CAUSED THE SOFT TISSUE PROBLEMS. THE CONSTRUCT WAS IMPLANTED APPROXIMATELY 6-9 MONTHS AGO. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17443485 ↗
• InjuryMay 25, 2023Break; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Break; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A BROKEN TFNA REMOVAL CASE. THE NAIL WAS PUT IN AT THE END OF JULY 2022 AND IS BELIEVED TO HAVE BROKEN AROUND MARCH 2023. THIS REPORT IS FOR ONE (1) UNK - NAIL HEAD ELEMENTS. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17001790 ↗
• InjuryMay 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A BROKEN TFNA REMOVAL CASE. THE NAIL WAS PUT IN AT THE END OF JULY 2022 AND IS BELIEVED TO HAVE BROKEN AROUND MARCH 2023. THIS REPORT IS FOR ONE (1) UNK - NAILS: TFNA. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 17001782 ↗
• InjuryOct 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THERE WAS A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR CONVERSION TO TOTAL HIP DUE TO CUT OUT. THERE WAS NO SURGICAL DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15620824 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF NAIL, HELICAL BLADE, AND LOCKING SCREWS FOLLOWED BY A TOTAL HIP REPLACEMENT SURGERY DUE TO TERRIBLE ARTHRITIS. INITIALLY, THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) ON AN UNKNOWN DATE. THE HARDWARE REMOVAL AND TOTAL HIP REPLACEMENT SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE (PART NUMBER 04.037.262S, LOT H735696, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 48MM FOR IM NAILS (PART NUMBER 04.005.538, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 11140237 ↗
• InjurySep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT A PATIENT EXPERIENCED A POST-OP DISPLACEMENT OF A FRACTURE. THE PATIENT RECEIVED THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANT ON (B)(6) 2020. A SURGEON, THAT DID NOT PERFORM THE INITIAL SURGERY, NOTED THAT THE HELICAL BLADE WAS INSERTED OUTSIDE OF THE HOLE IN THE NAIL. THE IMPROPER PLACEMENT OF THE HARDWARE CAUSED THE CONSTRUCT TO COLLAPSE. WHEN THE PATIENT TRIED TO WALK ON IT, THE FRACTURE BECAME DISPLACED AND THE PATIENT REQUIRED REVISION SURGERY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. THE HARDWARE WAS SUCCESSFULLY REMOVED, AND NEW HARDWARE WAS IMPLANTED. CONCOMITANT DEVICES REPORTED: SCREWS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 14MM/130 DEG TI CANN TFNA 440MM/RIGHT-STERILE (PART NUMBER 04.037.464S, LOT 38P3044, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TFNA FENESTRATED HELICAL BLADE 100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10487905 ↗
• InjuryMay 6, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE REMOVAL PROCEDURE ON (B)(6) 2020. THE HELICAL BLADE ADVANCED THROUGH THE NAIL AND WAS PENETRATED INTO THE PELVIS. THE PATIENT FELL AT THE NURSING HOME AND WAS UNABLE TO WALK. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: TITANIUM CANNULATED TROCHANTERIC FEMORAL NAIL ADVANCED STERILE (PART # 04.005.532, LOT # UNKNOWN, QUANTITY 1), TITANIUM LOCKING SCREW WITH T25 STARDRIVE 42MM FEMORAL INTRAMEDULLARY NAIL (PART # 04.005.532, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) FENESTRATED HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10029240 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) TO CONVERT TO A TOTAL HIP ARTHROPLASTY DUE TO POST-TRAUMATIC ARTHRITIS. THE PATIENT'S STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Arthritis

  MAUDE report 9929419 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION DUE TO THE PATIENT'S FEMUR BROKE DISTAL TO A SHORT TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) NAIL. THE TFNA NAIL , HELICAL BLADE AND DISTAL INTERLOCKING SCREW WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE IMPLANTED DEVICES WERE REMOVED AND A LONG TFNA WAS PUT IN ITS PLACE. THIS REPORT IS FOR ONE TFNA FENESTRATED HELICAL BLADE 100MM. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9707409 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) AFTER THE LOSS OF REDUCTION IN SUBTROCHANTERIC FRACTURE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2019. THE REMOVED DEVICES WERE THE FOLLOWING; ONE (1) DEGREE TITANIUM CANNULATED TFNA, ONE (1) TITANIUM LOCKING SCREW 46 MM, ONE (1) TITANIUM LOCKING SCREW 50 MM AND ONE (1) TFNA FENESTRATED HELICAL BLADE. PATIENT WAS REVISED TO A NEW NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8699469 ↗

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