NA 214117Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003587), received between Jul 2, 2019 and Mar 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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.

• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE STEM PULLED OUT OF THE HANDLE OF THE 8.5 X 55MM REUSABLE OBTURATOR DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHAFT WAS DETACHED FROM THE HANDLE (FELL APART). IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967508 ↗
• MalfunctionJul 3, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S 5.5 REUSABLE OBTURATOR SILICON HANDLE WAS CHIPPED, WHICH MADE IT HARD FOR THE SURGEON TO GRASP. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITHOUT PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE AVAILABILITY OF THE DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757716 ↗
• MalfunctionJul 2, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE THE CUSTOMER'S 5.5 REUSABLE OBTURATOR SILICON HANDLE WAS CHIPPED, WHICH MADE IT HARD FOR THE SURGEON TO GRASP. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITHOUT PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE AVAILABILITY OF THE DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752659 ↗