NA 399.17Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982202482), received between Oct 7, 2019 and May 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A MALLEOLAR CLAMP FOUND BROKEN IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072344 ↗
• MalfunctionNov 19, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE THREE CLAMPS OSTEOTOME, MALLEOLAR FORCEPS WITH TWO POINTS AND REDUCTION FORCEPS SPEED LOCK WERE MISSING THE OUTER NUT THAT HOLDS THE SPIN DOWN NUT IN. THEY HAD ALL BEEN BROKEN. THE ISSUE WAS FOUND OUT DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MALLEOLAR FORCEPS WITH TWO POINTS 210MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342257 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPIN-DOWN MECHANISM OF THE MALLEOLAR FORCEPS BROKE OFF. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MALLEOLAR FORCEPS WITH TWO POINTS 210MM. THIS IS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161948 ↗