NA 04.045.090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982293404), received between Jul 22, 2022 and Jul 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 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. How this data works · Data updated Oct 13, 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.

• InjuryJul 23, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024 PATIENT WAS BROUGHT INTO SURGERY BY SURGEON FOR A LOOSENING OF DISTAL INTERLOCKING SCREWS IN A SYNTHES RFNA FEMORAL NAIL. THE IMPLANT WAS INITIALLY PLACED BY SURGEON ON (B)(6) 2024 AT THE SAME FACILITY. AT SOME POINT AFTER THAT DATE THE PATIENTS NURSING HOME NOTICED PROMINENT HARDWARE AT THE SKIN. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR REVISION SURGERY ON (B)(6) 2024. THERE WAS AN INFECTION. THERE WAS NO SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) LOCKING SCREW FOR IM NAIL Ø 5MM/ 90MM/ XL25. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19806002 ↗
• 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/ 90MM/ XL25 FOR (B)(4).

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

  MAUDE report 17550153 ↗
• InjuryFeb 13, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST-OP PATIENT HAD A DISTAL FEMUR FRACTURE BACK IN OCTOBER AND NEEDED TO BE REVISED IN IN LATE DECEMBER. THE DISTAL M/L SCREW HAD BACKED OUT OF THE PATIENT AND THE SCREW NEEDED TO BE REMOVED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LOCKING SCREW FOR IM NAIL 5/ 90/ XL25. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16364151 ↗
• 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 OPERATING ROOM 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/ 90MM/ XL25. THIS IS REPORT 6 OF 7 FOR (B)(4).

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

  MAUDE report 15089411 ↗

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