NA 04.045.040SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982294425), received between May 19, 2023 and Jan 26, 2026 — classified as 2 injuries, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THE SCREW HEAD IS TORN OFF WHEN IT IS SCREWED IN. NO SURGERY DELAY OR PATIENT HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177600 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A BROKEN TNA NEEDED REMOVING AND RE-NAILING. THE NAIL HAD BROKEN AT THE DISTAL END. THE NAIL WAS ORIGINALLY IMPLANTED ON (B)(6) 2023, AND WAS REMOVED ON (B)(6) 2023 AND RE-NAILED WITH A 10X360MM TNA. ALL PREVIOUS NAIL ITEMS WERE REMOVED. THE REVISION PROCEDURE WAS PERFORMED BECAUSE OF THE BROKEN IMPLANT, THE FRACTURE HAD NOT HEALED. THE PATIENT HAD SIGNIFICANT DISTAL BONE LOSS AND A MASQUELET PROCEDURE WAS COMPLETED. THE PATIENT HAD BORNE WEIGHT AFTER BONE GRAFT HAD BEEN INSERTED, AND THIS IS WHEN THE NAIL BROKE. REAMINGS SENT OFF DURING THE CASE CAME BACK POSITIVE FOR INFECTION. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS PROGRESSING WELL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 40MM/ XL25/ STERILE. THIS IS REPORT 3 OF 7 FOR (B)(4).

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

  MAUDE report 17975199 ↗
• InjuryMay 19, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, THE SURGEON REPORTED TO SALES REP THAT HE HAD A PATIENT REPORT TO CLINIC WITH PAIN IN THE HIP REGION. THE PATIENT HAD A TFNA IMPLANTED FOR A HIP FRACTURE ON (B)(6) 2023. UPON TAKING A NEW X-RAY, SURGEON SAW THAT THE HELICAL BLADE HAD ESCAPED THE NAIL LATERALLY CAUSING THE FEMORAL NECK TO COLLAPSE, REQUIRING A REVISION SURGERY. UPON REMOVING THE NAIL, WE FOUND THAT THE INTERNAL LOCKING MECHANISM WAS BROKEN. SURGEON PERFORMED THE REVISION SURGERY SUCCESSFULLY IMPLANTING ANOTHER TFNA NAIL AND HELICAL BLADE. SURGEON HAD REQUESTED THAT THE NAIL BE INVESTIGATED AND WOULD LIKE A REPORT BACK OF ANY FINDINGS. THIS REPORT IS FOR ONE (1) LCKNG SCR FOR IM NL 5/ 40/ XL25/ SILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 16965528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A
• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A