OBTURATOR, Ø3.2mm PIN GUIDE 0616-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665002478), received between Feb 28, 2022 and Dec 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 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.

• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/18/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN 0312-200 PIN GUIDE WAS INSERTED INTO THE LAG SCREW GUIDE PIN SLEEVE. WHEN ADVANCING AND REDIRECTING FOR PROPER PLACEMENT, THE GUIDE PIN WELDED ITSELF TO THE GUIDE PIN SLEEVE. IT COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM. ALSO, THE CAP ON AN 0616-000 OBTURATOR HAD FALLEN OFF OR BECAME UNSTUCK FROM THE OBTURATOR ITSELF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744623 ↗
• MalfunctionFeb 28, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0616-000 OBTURATOR, PIN GUIDE, END CAP HAS DISCONNECTED FROM THE SHAFT. AND AN 0312-200 PIN GUIDE SPRING ATTACHMENT CLAMP THAT CONNECTS THE CLAMP TO THE LAG SCREW SHEATH HAS BROKEN AND CAN NO LONGER BE LOCKED TOGETHER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13621205 ↗