NA 04.045.068Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982292971), received between Mar 18, 2022 and Aug 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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.

• 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/ 68MM/ XL25 FOR (B)(4).

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

  MAUDE report 17550504 ↗
• InjuryApr 8, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, FACILITY HAS REVISED ANOTHER SCREW BACKING OUT OF A RFNA NAIL. SECOND REVISION SURGERY FOR THIS PATIENT WITH SAME ISSUES WITH SCREWS BACKING OUT. REMOVAL OF THE PROXIMAL TRANSVERSE SCREW. THE SCREW IS NOT AVAILABLE FOR RETURN. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - NAILS: RFNA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), THIS COMPLAINT INVOLVES ONE (1) DEVICE LOCKING SCREW FOR IM NAIL 5/ 68/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 14052852 ↗
• InjuryMar 18, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT REMOVAL OF 74MM & 68MM 5.0MM LOCKING SCREWS DUE TO BACK OUT. THE PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 68MM/ XL25 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 13805088 ↗

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 A
• 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