TFN-ADVANCE 04.038.310SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982099075), received between Mar 15, 2018 and Jan 24, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryJan 24, 2019Break; Break

  X-RAY REVIEW WAS CONDUCTED: X-RAYS TAKEN AT 2 MONTHS SHOWS LOOSENING/MIGRATION OF DISTAL INTERLOCKING SCREW. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8275869 ↗
• InjuryOct 9, 2018Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANTS DUE TO DISCOMFORT IN THE OPERATIVE HIP. THE HELICAL BLADE IMPLANT HAD CUT-OUT INTO THE ACETABULUM, CAUSING IRRITATION. PATIENT WAS REVISED TO TOTAL HIP ARTHROPLASTY. TFNA HARDWARE WAS ORIGINALLY IMPLANTED IN (B)(6) 2017. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: 5.0MM TITANIUM (TI) LOCKING SCREW-STERILE (PART: 04.005.528S, LOT: H329932, QUANTITY: 1), 10MM/130 DEGREE TI CANNULATED TFNA NAIL (PART: 04.037.042S, LOT: H346500, QUANTITY 1). THIS REPORT IS FOR A TFNA HELICAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 7947857 ↗
• InjuryApr 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANT ON (B)(6) 2018, WAS REVISED TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2018, DUE TO WHAT LOOKED LIKE AN IMPENDING CUT OUT OF THE HELICAL BLADE. REPORTEDLY THE PATIENT WAS HEALING BUT POST-OPERATIVE X-RAYS SHOWED THAT THE DEVICE APPEARED TO BE ON ITS WAY TO CUT OUT DUE TO HIS VERY OSTEOPOROTIC BONE. THE HELICAL BLADE, THE TROCHANTERIC FIXATION NAIL, AND ONE 5.0 TITANIUM LOCKING SCREW WERE REMOVED INTACT WITHOUT ANY ADDITIONAL MEDICAL INTERVENTION OR INTRAOPERATIVE EVENTS. THE PATIENT WAS SUCCESSFULLY REVISED WITH NO SURGICAL DELAYS AND WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: 11MM 130 DEGREE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL- ADVANCED (PART 04.037.144S, LOT NUMBER H488085, QUANTITY 1), 5.0MM TITANIUM LOCKING SCREW WITH T/25 STARDRIVE 48MM FOR INTRAMEDULLARY NAILS (PART 04.005.538, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TFNA HELICAL BLADE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7401258 ↗
• InjuryApr 5, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2018 FOR A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) FOR A HIP FRACTURE. POST SURGERY, SURGEON REALIZED THAT THE HELICAL BLADE USED WAS TOO LONG AND NOTIFIED THE SALES CONSULTANT ON (B)(6) 2018 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018. THE REASON FOR THE REVISION SURGERY WAS THAT THE HELICAL BLADE USED WAS TOO LONG. THE WRONG BLADE SIZE WAS CHOSEN. THE HELICAL BLADE WAS REMOVED INTACT, THE SCREW WAS REMOVED INTACT, THE NAIL BROKE WHILE TRYING TO REMOVE IT. THE NAIL WOULD NOT LATCH ONTO THE NAIL EXTRACTOR AFTER SEVERAL ATTEMPTS AND RESULTED IN THE TIP BREAKING AND THE BOTTOM PORTION REMAINING IN THE PATIENT. A NEW SET OF INSTRUMENTS HAD TO BE USED TO COMPLETE THE SURGERY AND THERE WAS A THREE HOUR DELAY. THE REVISION SURGERY ENTAILED A SHORTER BLADE AND A LONGER SCREW AND NAIL. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS SATISFACTORY. NO X-RAYS AVAILABLE. CONCOMITANT MEDICAL PARTS: (TFNA SCREW 95MM) PART: 04.038.095S, LOT: H523636, QUANTITY ONE; (11MM/130 DEG TI CANN TFNA) PART: 04.037.142S, LOT: H492789, QUANTITY ONE. THIS IS

  Patient problems: No Code Available

  MAUDE report 7400935 ↗
• InjuryMar 15, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) ON (B)(6) 2018 DUE TO HELICAL BLADE CUT OUT. ONE 110MM HELICAL BLADE, ONE 5.0MM LOCKING SCREW, AND ONE CANNULATED NAIL WERE EXPLANTED. THE HARDWARE WAS ORIGINALLY IMPLANTED ON AN UNKNOWN DATE IN EARLY (B)(6) 2018. PATIENT WALKED TOO SOON AND THE HELICAL BLADE PENETRATED THROUGH THE FEMORAL HEAD. A REMOVAL AND A HEMIARTHROPLASTY WERE PERFORMED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS AND NO TIME DELAY. PATIENT STATUS FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 5.0MM LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QTY: 1); 12MM CANNULATED NAIL (PART # 04.037.261S, LOT # H325954, QTY: 1). (B)(4).

  Patient problems: No Code Available

  MAUDE report 7343110 ↗

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-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-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-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