NA 04.045.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982292773), received between Aug 14, 2023 and Apr 4, 2024 — 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.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 40MM/ XL25 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19044545 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED (B)(6) 2024 DUE TO A MALUNION/NONUNION. SURGEON REMOVED ALL IMPLANTS THAT WERE CURRENTLY IN PATIENT. RIA WAS USED TO COLLECT BONE GRAFT AND CLEAN OUT THE SURGICAL SITE. SURGEON INSERTED NEW IMPLANTS AFTER RESTORING ALIGNMENT AND LENGTH. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN HOW LONG THE DEVICES HAVE BEEN IMPLANTED FOR. THIS REPORT IS FOR ONE LOCKING SCREW FOR IM NAIL 5/ 40/ XL25 FOR (B)(6) 2024.

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19043179 ↗
• 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/ 40MM/ XL25 FOR (B)(4).

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

  MAUDE report 17549629 ↗
• 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/ 40/ XL25 IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541179 ↗

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