N/A OM-9630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470002928), received between Jun 10, 2019 and Jun 10, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionJun 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE SURGERY, THE SURGEON WAS REMOVING AN OLD ANCHOR WITH A SCREWDRIVER. THE END OF THE SCREWDRIVER BROKE OFF IN THE OLD ANCHOR. IT IS UNKNOWN IF THERE WAS A DELAY IN THE CASE OR IF A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO MORE INFORMATION WAS AVAILABLE ON MEDWATCH FORM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8683536 ↗