R3 71935330Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556613566), received between Jan 17, 2020 and Jan 17, 2020 — 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.

• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE REAMER BROKE DURING USE. THE PIECE THAT BROKE OFF WAS REMOVED FROM THE PATIENT IMMEDIATELY. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603865 ↗