DHS 338.11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982193162), received between Aug 19, 2022 and Apr 6, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Failure to Cut

  IT WAS REPORTED THAT THERE WAS A DULL REAMER AND BARREL REAMERS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793740 ↗
• MalfunctionApr 6, 2026Failure to Cut

  IT WAS REPORTED THAT THERE WAS A DULL REAMER AND BARREL REAMERS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793729 ↗
• 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-STANDARD. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261022 ↗