SPEEDSCREW OM-9820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470002584), received between Jul 12, 2021 and Jul 12, 2021 — classified as 1 injury.

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 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.

• InjuryJul 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR CASE WITH A HEALICOIL KNOTLESS SELF-TAPPING ANCHOR, A PUNCH TAP WAS USED TO PREPARE THE BONE HOLE. HOWEVER, HALFWAY THROUGH THE PREPARATION, THE TIP SNAPPED AND REMAINED LODGED IN THE BONE. AN ADDITIONAL BONE HOLE WAS NEEDED TO USE THE ANCHOR. IT IS UNKNOWN IF THERE WAS A DELAY, NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12155633 ↗