NA 04.045.042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982292780), received between Aug 25, 2021 and Nov 24, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A TFNA NAIL WAS BROKEN AFTER PSEUDOARTHROSES. PATIENT UNDERWENT REOPERATION AS A RESULT OF THE EVENT. DURING INVESTIGATION OF THE RETURNED DEVICES, IT WAS NOTED THE SCREW WAS BROKEN.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23632341 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT SUSTAINED INJURIES AS A RESULT OF TRIP AND FALL OVER A SECURITY BAND ON THE EXTERIOR SIDEWALK PREMISES OF THE STORE. AFTER A MECHANICAL FALL FROM STANDING, IMAGING SHOWED RIGHT DISTAL FEMUR FRACTURE AND LEFT PROXIMAL HUMERUS FRACTURE. ON (B)(6) 2022 THE PATIENT UNDERWENT IMN OF RIGHT FEMUR. OPEN REDUCTION INTERNAL FIXATION (ORIF) OF LEFT HUMERUS FRACTURE ON (B)(6) 2022. HE WAS DISCHARGED TO FOR ACUTE REHAB ON (B)(6) 2022. ON (B)(6) 2023 THE PATIENT WAS ADMITTED FOR RIGHT FEMUR NONUNION REVISION, WITH WORSENING RIGHT THIGH PAIN AND IMPAIRED MOBILITY. THE PATIENT HAD ANTIBIOTIC MANAGEMENT OF RIGHT FEMORAL OSTEOMYELITIS. THIS REPORT IS FOR A LOCKING SCREW FOR IM NAIL Ø 5MM/ 42MM/ XL25 FOR (B)(4).

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

  MAUDE report 17549122 ↗
• MalfunctionAug 14, 2023Material Twisted/Bent; Material Twisted/Bent

  DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE DEVICE IT WAS IDENTIFIED THAT LOCKING SCREW FOR IM NAIL 5/ 42/ XL25 IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541645 ↗
• InjuryAug 25, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REVISION SURGERY AND REMOVAL OF HARDWARE FOR THE RETROGRADE FEMORAL NAILING SYSTEM(RFNA) WAS IMPLANTED ON A PRIOR DATE. BROUGHT BACK FOR REVISION SURGERY AND REMOVAL OF HARDWARE ON (B)(6) 2021. THE 5MM X 42MM SCREW HAD BACKED OUT OF THE NAIL. THE NAIL AND ALL FOUR SCREWS WERE REMOVED AND REPLACED WITH A VA CONDYLAR PLATE. CONCOMITANT DEVICE REPORTED: RFNA / 10 / 300 5 DEG BEND / STERILE (PART# 04.233.030S; LOT# 73P8202; QUANTITY: 1); LOCKING SCREW FOR IM NAIL 5/ 76/ XL25 (PART# 04.045.076; LOT# UNKNOWN; QUANTITY: 2); LOCKING SCREW FOR IM NAIL 5/ 36/ XL25 (PART# 04.045.036; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 42/ XL25. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12367267 ↗

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