NA 03.037.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982258809), received between Jun 25, 2019 and Jun 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryJun 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL NAILING SURGERY WITH THE RIGHT TROCHANTERIC FEMORAL NAILING SYSTEM ADVANCED (TFNA) INTRAMEDULLARY NAIL FOR A SUB-TROCHANTERIC FEMORAL FRACTURE ON (B)(6) 2019. THE FRACTURE WAS DIFFICULT TO REDUCE. BEFORE IMPLANTATION, THE NURSING STAFF AND THE SURGEON TESTED TO INSERT THE LAG SCREW INTO THE NAIL AND HAD NO ISSUES WITH THE JIG. DURING IMPLANTATION, THE NAIL AND LAG SCREW WAS IMPLANTED WITH SOME DIFFICULTY IN THE INSERTION OF THE NAIL. DISTAL CROSS BOLTS WERE THEN IMPLANTED AND THE JIG WAS REMOVED. IN THE FINAL SHOTS, THE SCREW APPEARED TO HAVE MISSED THE NAIL. THE SURGEON REMOVED THE LAG SCREW AND THEN WITH THE ASSISTANCE OF ANOTHER SURGEON REINSERTED THE LAG SCREW AFTER CONNECTING THE JIG INTO THE NAIL IN-SITU. X-RAYS WERE THEN TAKEN AND WAS CONFIRMED THAT THE LAG SCREW WAS SUCCESSFULLY RE-POSITIONED TO THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 45 MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TFNA NAIL (PART# 04.037.028S, LOT# H309035, QUANTITY# 1); LOCKING SCREW (PART# 04.005.530S, LOT# 2L43586, QUANTITY

  Patient problems: No Code Available

  MAUDE report 8730679 ↗

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-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
• 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