NA 04.043.560SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982297983), received between Jan 13, 2023 and Mar 21, 2023 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K201336); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT FROM CLINICAL STUDY (B)(6) FOR SUBJECT (B)(6). ADVERSE EVENT TERM: NON UNION SITE AWARENESS DATE: (B)(6) 2023 START DATE: (B)(6) 2023 TYPE OF EVENT: LOCAL/FRACTURE SITE SIDE: LEFT DEVICE: TNA SEVERITY: MILD SERIOUS: NO RELATIONSHIP TO STUDY DEVICE: NOT RELATED RELATIONSHIP TO STUDY PROCEDURE: POSSIBLE THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 13MM 420MM / STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Post Operative Wound Infection

  MAUDE report 16582745 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT SURGERY TO IMPLANT A LEFT SIDE TNA ON NOVEMBER 23, 2022 AFTER SUSTAINING AN OPEN DISTAL TIBIAL FRACTURE. ON (B)(6)2022, INCISIONAL DRAINAGE WAS NOTED AND TRAUMATIC WOUND INFECTION WAS DIAGNOSED. THE PATIENT WAS TREATED WITH ORAL/TOPICAL MEDICATION (KEFLEX 500MG TID, BACTRIM DS 800MG/160MG BID). IRRIGATION AND DEBRIDEMENT WAS PERFORMED AT THE SURGICAL SITE ON (B)(6)2022. THE OUTCOME WAS RECOVERED/RESOLVED. AT THEIR 3-MONTH AND THE 6-MONTH FOLLOW-UP VISITS, BONE UNION HAD NOT YET BEEN ACHIEVED. A BONE STIMULATOR WAS USED FOR TREATMENT. THE OUTCOME WAS RECOVERING/RESOLVING.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Post Operative Wound Infection

  MAUDE report 16159023 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. 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