NA 399.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982202376), received between Jul 30, 2019 and Jul 10, 2025 — 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.

• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CLAMP WAS FOUND BROKEN IN STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473148 ↗
• MalfunctionOct 25, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED A BONE HOLDING FORCEP WAS BROKEN. IT IS UNKNOWN WHEN THE DEVICE BROKE. NO KNOWN PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A FORCEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666229 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BONE HOLDING FORCEPS WAS BEING WASHED AT THE STERILE PROCESSING DEPARTMENT, GOT CAUGHT AT ONE SIDE OF THE CASES, AND AS THEY TRIED TO REMOVE BY PUTTING A LOT OF FORCE ON IT, THE TIP OF THE BONE HOLDING FORCEPS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A BONE HOLDING FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8842954 ↗