NA 04.045.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982292735), received between Apr 28, 2022 and Sep 23, 2024 — classified as 2 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 (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. How this data works · Data updated Oct 13, 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.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT WAS SCHEDULED WITH A BROKEN FEMUR FRACTURE BELOW THE CURRENT IMPLANT. DOCTOR REMOVED TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPLANTS WITHOUT ANY ISSUES - ALL HARDWARE WAS INTACT AND NOTHING WAS BROKEN. DOCTOR THEN IMPLANTED A NON-SYNTHES INTERTAN NAIL TO ADDRESS THE FRACTURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 32MM/ XL25.

  Patient problems: Limb Fracture

  MAUDE report 20280954 ↗
• InjuryJul 22, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT SUSTAINED AN OPEN DISTAL FEMUR FRACTURE FROM A GUNSHOT WOUND. THE FRACTURE WAS TREATED WITH A RETROGRADE FEMORAL NAIL AND INTERLOCKING SCREWS. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A SUSPECTED INFECTION. X-RAY IMAGES SHOWED DELAYED UNION AND THE MIGRATION OF ONE OBLIQUE DISTAL INTERLOCKING SCREW . ON (B)(6) 2022, PATIENT WAS BROUGHT TO THE OR FOR IRRIGATION AND DEBRIDEMENT AND REMOVAL OF MIGRATED SCREW. THE SCREW LOW PROF LCKNG SCR 5.0 / L 64 / XL25 WAS REMOVED AND REPLACED WITH SCREW LOCKING SCREW FOR IM NAIL 5/ 90/ XL25. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 32MM/ XL25. THIS IS REPORT 5 OF 7 FOR (B)(4).

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

  MAUDE report 15089381 ↗
• MalfunctionApr 28, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT ON (B)(6), 2022, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. ACCORDING TO THE REPORT, THE RETENTION PIN BROKE OFF IN THE HEAD OF 5.0 XL LOCKING SCREW DURING PROXIMAL SCREW INSERTION OF A RETROGRADE NAIL. FRAGMENTS WERE GENERATED AND WERE REMOVED. EXTRA INTRAOPERATIVE X-RAY WAS REQUIRED FOR SCREW REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF SEVEN MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 32/ XL25 DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14244683 ↗

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-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 Adva
• 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 Adva