NA SD399.099Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982007087), received between Sep 8, 2021 and Feb 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024 THAT THE DOCTOR WAS REDUCING BONE AND TIP OF LOBSTER CLAW FLEW OFF. NO SURGICAL DELAY. NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS WITH EXTENDED RATCHET THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669740 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ORTHOPEDIC PROCEDURE, THE CLAMP WAS BROKEN AND THE SURGEON HAD TO USE A DIFFERENT CLAMP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) REDUCTION FORCEPS WITH EXTENDED RATCHET. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440726 ↗