Equinoxe 321-52-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862580757), received between Jan 7, 2022 and Jan 7, 2022 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE THE K-WIRE WAS IN THE GLENOID AND WHEN IT WAS TIME TO USE THE MINI BASEPLATE DRILL TO DRILL THE CENTER CAGE, THE K-WIRE TIP STARTED TO BREAK APART. THE TIP WAS THEN STUCK IN THE DRILL. BOTH DEVICES WERE REMOVED AND NEW ONES WERE USED TO COMPLETE THE CASE. NO PATIENT INFORMATION OR MEDICAL HISTORY REPORTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190297 ↗