Equinoxe 319-01-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862538789), received between Oct 23, 2023 and Oct 23, 2023 — 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.

• MalfunctionOct 23, 2023Break; Break

  IT WAS REPORTED THAT THE SURGEON ATTACHED THE INSERTER TO THE SIZE 2 STEMLESS BROACH AND WENT TO BACK THE BROACH OUT AND THE HANDLE KEPT COMING LOOSE AFTER FURTHER LOOKING AT THE HANDLE IT WAS DISCOVERED THAT THE HANDLE HAD COME APART. ONE SMALL PART FROM THE TOP OF THE HANDLE FELL ON THE FLOOR AND THE OTHER PARTS OF THE HANDLE WERE SET ON THE BACK TABLE. SURGEON STILL NEEDED TO REMOVE THE SIZE 2 BROACH SO HE USED THE CAGE EXTRACTION INSTRUMENT FROM THE ERGO ANATOMIC TRAY. HE ATTACHED IT TO THE BROACH ALONG WITH A SMALL SLAP HAMMER AND BACK THE BROACH OUT WHICH CAME OUT. HE THEN PROCEEDED TO PUT IN THE FINAL IMPLANT AND RUN IT THOUGH A RANGE OF MOTION. THEN HE REPAIRED THE SUB SCAP AND CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PART OFF PIECES FELL INTO THE WOUND SITE. NO IMAGES OR X-RAYS AVAILABLE. DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984943 ↗