NA 02.233.104SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982289285), received between Mar 18, 2022 and Jul 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201346, K233696); 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.

• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS ADVERSE AN EVENT FOR RIGHT NONDISPLACED TIBIAL SHAFT FRACTURE. THIS REPORT IS FOR ONE (1) LOCKING ATTACHMENT WASHER F/ RFNA / 10 DEG/ RIGHT/ STER. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

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

  MAUDE report 17329576 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT CRF CASEBOOK FOR SUBJECT (B)(6). THE CRFS INCLUDE ADVERSE EVENT NONUNION OF RIGHT DISTAL FEMUR AND REVISION DETAILS FORM. ADVERSE EVENT TERM: NONUNION OF RIGHT DISTAL FEMUR, SITE AWARENESS DATE:(B)(6) 2023 START DATE: (B)(6) 2023 SIDE: RIGHT, DEVICE: RFNA, RELATIONSHIP TO STUDY DEVICE: NOT RELATED, RELATIONSHIP TO STUDY PROCEDURE: NOT RELATED. THIS REPORT IS FOR A LOCKING ATTACHMENT WASHER F/ RFNA / 10 DEG/ RIGHT/ STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16436303 ↗
• MalfunctionMar 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 WHEN SURGEON WAS USING THE PLATE WITH THE GUIDE, THE DISTAL TWO HOLES DID NOT LINE UP CORRECTLY WITH THE GUIDE AND DRILL SLEEVE. THE GUIDE WAS CHECKED TO MAKE SURE IT WAS ATTACHED PROPERLY. ANOTHER PLATE WAS OPENED UP AND IT LINED UP PROPERLY. THERE WAS NO SURGICAL DELAY REPORTED. SURGERY WAS COMPETED SUCCESSFULLY. THIS REPORT IS FOR (1) LOCKING ATTACHMENT WASHER F/ RFNA / 10 DEG/ RIGHT/ STER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346, K233696. 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