REUNION 5901-1103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327099409), received between Dec 10, 2018 and Jan 27, 2021 — 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.

• MalfunctionJan 27, 2021Fracture; Fracture

  AS REPORTED: "THE SURGEON WAS BROACHING THE HUMERUS WITH THE BROACH HANDLE AND VERSION ROD SCREWED INTO THE BROACH. AS THE SURGEON WAS BACKING THE BROACH OUT, HE HIT THE ALIGNMENT ROD AND IT SNAPPED LEAVING A PIECE OF THE THREAD STUCK INSIDE THE 30° SLOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11241266 ↗
• MalfunctionDec 10, 2018Break; Naturally Worn

  UPON INCOMING INSPECTION, ITEM WAS VISIBLY WORN. NO FURTHER INFORMATION IS AVAILABLE. BROKEN TIP AT THE THREADS.

  Patient problems: No Information

  MAUDE report 8148507 ↗