MOUNTAINEER 288312000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034221779), received between Jul 13, 2017 and May 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WORN DUE TO USE. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221528 ↗
• MalfunctionMay 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WORN DUE TO USE. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221527 ↗
• MalfunctionJan 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS WORN DUE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011930 ↗
• MalfunctionJul 13, 2017Break; Break

  REPORTED BY COMMERCIAL COORDINATOR IN (B)(6). WE HAVE ALSO PRODUCT COMPLAINTS IN (B)(4) DEPUY (ORTHOKIT/LOANER SITE) FOR 2017 YEAR. DEVICES QUARANTINED DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711738 ↗