DHS 338.44Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982193476), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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.

• MalfunctionAug 19, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE FOLLOWING PRODUCT ISSUES WERE DISCOVERED. BOTH THE STANDARD LENGTH AND SHORT DHS REAMING HEADS WERE FOUND TO BE DULL. THE 8MM DRILL BIT FOR THE REAMER WAS ALSO FOUND TO BE DULL. THE DHS IMPACTOR WAS FOUND TO HAVE FRACTURED AT THE TIP. THIS REPORT IS FOR A DHS® REAMING HEAD-SHORT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260976 ↗