DHS 338.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982193179), received between Apr 13, 2023 and Dec 19, 2023 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED A REAMER DOESN'T CUT ANYMORE. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR DHS TRIPLE REAMER-COMPLETE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356453 ↗
• MalfunctionApr 13, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023, THE DHS TRIPLEREAMER (338.130) CAUGHT AND CUT INTO GUIDE WIRE (338.000S). NO FRAGMENTS WERE GENERATED. THE WIRE WAS REPLACED AND SURGERY WAS CONTINUED AFTER A 5 MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A DHS® TRIPLE REAMER-COMPLETE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16734462 ↗