TFN-ADVANCE 04.038.080SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982098436), received between Feb 22, 2018 and Feb 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT A LAG SCREW WAS MISALIGNED AND TWO DRILL BITS BROKE DURING A FEMORAL NAILING PROCEDURE ON (B)(6) 2018. THE TIP OF A 10MM CANNULATED TAPERED DRILL BIT BROKE OFF WHILE THE SURGEON WAS OPENING THE LATERAL CORTEX. THEN, A 6MM/9MM CANNULATED STEPPED DRILL BIT BROKE WHILE THE SURGEON WAS REAMING THE FEMORAL HEAD. FRAGMENTS WERE LEFT IN THE BONE FROM BOTH BROKEN BITS. THE LAG SCREW FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) WENT ANTERIOR TO THE NAIL; THIS WAS CAUGHT IN FINAL FLUOROSCOPY TOWARD THE END OF THE PROCEDURE AND HAD TO REPLACED THE DEVICE. IT BACKED OUT, THE HANDLE PLACED BACK ON THE NAIL AND THE SAME LAG SCREW WAS SHOT (IMPLANTED) IN THE RIGHT TRAJECTORY. THERE WAS A SURGICAL DELAY OF ABOUT TWO HOURS DUE TO THESE MALFUNCTIONS, THEREFORE AND EXTRA FLUOROSCOPY WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICE REPORT: [UNKNOWN AIMING ARM] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1), [UNKNOWN TROCARS] {PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 3), [UNKNOWN STRYKER POWER DRILL] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS COMPLAINT IS FOR THREE (3) DEVICES. THIS REPORT IS 3 OF 3 FOR (B

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. 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
• 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-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-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