REUNION 5901-0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327099300), received between May 10, 2019 and May 10, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT SHOULDER, THE TIP OF THE CENTERING DRILL BROKE OFF IN THE PATIENT WHEN DRILLING THROUGH THE CENTERING GUIDE. PIECE WAS REMOVED FROM PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF UNDER ONE MINUTE.

  Patient problems: No Code Available

  MAUDE report 8601876 ↗