TFN-ADVANCE 04.038.385Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982099228), received between Jun 2, 2020 and Jul 17, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Break; Break

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TFNA NAIL AND BLADE IN QUESTION GOT BROKEN UP. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TFNA FENESTRATED HELICAL BLADE 85MM. THIS IS REPORT 2 OF 2 FOR (B(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335335 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE (04.037.012) X1 TFNA 10X170MM 125 DEGREE LEFT, (04.038.385) X1 HELICAL BLADE 85MM AND (04.005.5) X1 SCREW 5.0X MM WERE REVISED DUE TO TOTAL HIP ARTHROPLASTY. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TFNA FENESTRATED HELICAL BLADE 85MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 16223168 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS UNDERWENT A REVISION OF FEMUR NAIL DUE TO ANTERIOR THIGH PAIN. THERE WAS NO SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 13908633 ↗
• InjuryNov 18, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION HIP SURGERY TO EXTRACT A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) NAIL AND A HELICAL BLADE FOLLOWED BY A HEMI HIP ARTHROPLASTY AS THE HELICAL BLADE HAD PENETRATED THROUGH THE FEMORAL HEAD EIGHT (8) WEEKS AFTER IMPLANTATION. INITIALLY, THE PATIENT WAS IMPLANTED WITH A TFNA NAILING SYSTEM ON AN UNKNOWN DATE. CONCOMITANT DEVICES REPORTED: TFNA NAIL (PART # 04.037.012S, LOT # 53P5981, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA FENESTRATED HELICAL BLADE 85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10863935 ↗
• InjuryJun 2, 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 OF AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO ADDRESS A NON-UNION OF THE MID-SHAFT FEMUR PREVIOUSLY FIXATED WITH A 1 TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL 14MM LONG, 1 UNKNOWN 85MM LAG SCREW AND 2 TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS. THE PREVIOUS SURGERY WAS PERFORMED IN 2017. THERE WAS NO BROKEN HARDWARE PRESENTED, BUT A SUSPECTED INFECTION WAS PRESENT WHICH MAY HAVE CAUSED THE NON-UNION. THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, UNKNOWN LAG SCREW, AND TITANIUM (TI) LOCKING SCREW WITH T25 STARDRIVE 40MM FOR IM NAILS WERE SUCCESSFULLY REMOVED WITHOUT BREAKAGE. THE SYNTHES RIA SYSTEM WAS USED TO CLEAR THE FEMORAL CANAL OF ANY PRESENT INFECTION. 10CC OF NORIAN WAS THEN IMPLANTED INTO THE PROXIMAL FEMUR WHERE THE PREVIOUS UNKNOWN LAG SCREW SAT. A 9X380 FRN-GT NAIL WAS OPENED AND ANTIBIOTIC CEMENT WAS WRAPPED AROUND THE NAIL. THE NAIL WAS THEN INSERTED INTO THE FEMUR TO ADDRESS THE NON-UNION. THE NAIL WAS LOCKED PROXIMALLY USING ONE 6.5 RECON SCREW AND ONE 5.0 LOCKING SCREW. THE NAIL WAS ALSO DISMALLY LOCKED USING TWO 5.0 INTERLOCKING SCREWS. THE PROCEDURE O

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

  MAUDE report 10111395 ↗

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-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-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