NA 2361-5047SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327381719), received between Apr 8, 2020 and Feb 13, 2026 — classified as 1 injury, 1 malfunction.

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

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.

• MalfunctionFeb 13, 2026Malposition of Device

  AS REPORTED: "DUE TO INSUFFICIENT ADJUSTMENT OF THE ADJUSTING DEVICE, THE MOST DISTAL ADVANCE LOCKING SCREW OF THE TWO DISTAL TRANSVERSE STOPS WAS INSERTED INTO THE BONE WITHOUT PASSING THROUGH THE NAIL. THIS WAS DISCOVERED AFTER WOUND CLOSURE. REINSERTION OF THE SCREW OUTSIDE THE NAIL WAS NOT PERFORMED, AND THE PLAN IS TO OBSERVE THE SITUATION AND TAKE ACTION AS APPROPRIATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332519 ↗
• InjuryApr 8, 2020Migration; Migration

  THIS REPORT IS FOR THE SECOND SCREW BACK-OUT ("THE OTHER 2 DISTAL SCREWS"). AS REPORTED: "THE MOST DISTAL T2 ALPHA SCREW IN THE TIBIA NAIL BACKED OUT AND HAD TO BE REMOVED. THE SCREW WAS AN ADVANCED LOCKING SCREW AND WAS REMOVED IN CLINIC. TWO DAYS LATER, THE OTHER 2 DISTAL SCREWS (ADVANCED LOCKING SCREWS) ALSO BACKED OUT. THIS EVENT HAPPENED 2 AND 2.5 WEEKS POST OP".

  Patient problems: Failure of Implant; Injury

  MAUDE report 9941409 ↗