NA 0226-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540145550), received between Oct 10, 2022 and Oct 10, 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. 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.

• MalfunctionOct 10, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT : "BREAKAGE OF THE REAMER STRYKER ADAPTOR IN INTRAOPERATIVE WITH THE REAMER HEAD REMAINING IN THE PATIENT'S BONE." ACTION TAKEN : REMOVE THE ALESOR INTRODUCED INTO THE FEMUR. CUSTOMER REPORTED THAT: "INCIDENTAL DESCRIPTION: DURING A FEMUR NAILING PROCEDURE, THE MOTOR ADAPTER OF THE STRYKER REAMER BROKE WHILE THE SURGEON WAS USING IT ON THE PATIENT." CLINICAL CONSEQUENCES FOUND: ACTIVITY PERFORMED WITH A LOSS OF TIME AND/OR QUALITY CONSERVATIVE MEASURES AND ACTIONS TAKEN: REMOVE THE REAMER INSERTED IN THE FEMUR + THE GUIDE PIN WHICH WERE NO LONGER ATTACHED TO THE MOTOR ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569224 ↗