NA 04.043.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982297754), received between Jul 8, 2022 and Jun 1, 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 (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 16, 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.

• InjuryJun 1, 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 A LOCAL INFECTION WORSENING OF AN EXISTING EVENT OF BLOWTORCH INJURY STAGE II. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 300MM / STERILE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17041010 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRFS FOR SUBJECT 00164-010 FOR THE CLINICAL STUDY DST202103 WERE REVIEWED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 300MM / STERILE. THIS IS REPORT 1 OF 10 FOR (B)(4).

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

  MAUDE report 16861695 ↗
• MalfunctionJul 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A TIBIAL SHAFT FRACTURE. BEFORE INSERTION OF THE NAIL, THE SURGEON CHECKED THE CONNECTION OF AN INSERTION HANDLE AND AIMING ARM AND JUDGED THAT THERE WOULD BE NO PROBLEM IN DRILLING TO THE PROXIMAL STATIC 1 HOLE. THE SURGEON TIGHTENED A CONNECTING SCREW THAT HAD LOOSENED, CONNECTED THE AIMING ARM TO THE INSERTION HANDLE, AND DRILLED AT THE PROXIMAL STATIC 1 HOLE OVER A SLEEVE. WHILE DRILLING, THE TIP OF THE DRILL BIT AND THE HOLE INTERFERED, AND THE SURGEON COULD NOT DRILL TO THE END. THE CONNECTING SCREW WAS TIGHTENED AGAIN, BUT THE INTERFERENCE OCCURRED AGAIN. THE SURGEON DRILLED MANUALLY WITHOUT THE SLEEVE AND SUCCEEDED IN INSERTING A SCREW INTO THE PROXIMAL STATIC 1 HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 300MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960006 ↗

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-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