DHS 280.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982175151), received between May 19, 2025 and May 19, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PILON, TWO VOLT HOOK PLATES WERE USED AND THE HOOKS BROKE OFF WHEN TRYING TO MALLET IN THE MEDIAL MALLELOUS. VARIABLE ANGLE (VA) MEDIAL PLATE WAS ALSO USED AND A SCREW WAS NOT LOCKING IN. DURING A DHS IN SAME CASE, A 90MM LAG SCREW WAS STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047205 ↗
• MalfunctionMay 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PILON, TWO VOLT HOOK PLATES WERE USED AND THE HOOKS BROKE OFF WHEN TRYING TO MALLET IN THE MEDIAL MALLEOLUS. VARIABLE ANGLE (VA) MEDIAL PLATE WAS ALSO USED AND A SCREW WAS NOT LOCKING IN. DURING A DHS IN SAME CASE, A 90MM LAG SCREW WAS STRIPPED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047199 ↗