NA 03.311.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982077806), received between Nov 4, 2022 and Jan 31, 2023 — 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. 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.

• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE,WHILE PERFORMING MAXFRAME CASE, ONE OF THE RATCHETING WRENCHES WAS BROKEN, AND NO LONGER RATCHETS. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) RATCHET WRENCH 11MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273290 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE TAKING APART A MAXFRAME CONSTRUCT, THE WRENCH IN QUESTION BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS EVENT OCCURRED AFTER SURGERY IN THE STERILE PROCESSING DEPARTMENT. THIS REPORT INVOLVES ONE RATCHET WRENCH 11MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15740466 ↗