NA 03.605.527Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034712673), received between May 11, 2021 and Sep 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 30, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE FORCEPS WAS DAMAGED. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED. THE PATIENT OUTCOME UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)PITUITARY RONGEUR-STRAIGHT 4MM WIDTH. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558244 ↗
• MalfunctionSep 9, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PITUITARY RONGEUR STRAIGHT, DUAL-SIDED RASP BAYONETED, DEG ANGLED RASP-BAYONETED, (2) BONE CURETTE, BOX CURETTE, OSTEOTOME STRAIGHT, (2) BOX CURETTE, RINGCURETTE AND CONCORDE BONE FUNNEL WERE BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) PITUITARY RONGEUR-STRAIGHT 4MM WIDTH. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449918 ↗
• MalfunctionMay 11, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS DISCOVERED TO HAVE FOUR BLACK DOTS AND A RING AROUND IT. THIS FOREIGN SUBSTANCE WAS FOUND AND THE DEVICE WAS REJECTED. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) PITUITARY RONGEUR-STRAIGHT 4MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805633 ↗