Speed Hand and Wrist DK-200HWRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633021835), received between Dec 28, 2020 and Aug 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709824 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (SD314.001).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709739 ↗
• MalfunctionDec 28, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS USING OUR BME SPEED IMPLANTS DURING INTERCARPAL FUSION. A DRILL KIT FOR BME SPEED WAS OPENED, HOWEVER, THERE WAS NO 15MM DRILL GUIDE PRESENT IN THE KIT. INSTEAD, THERE WERE TWO 13MM DRILL GUIDES ALONG WITH THE 9MM AND 11MM DRILL GUIDES. THE SURGEON OPENED ANOTHER DK-200HW DRILL KIT. THERE WAS NO SURGICAL DELAY IN THE CASE, THE SURGEON WAS ABLE TO OPEN ANOTHER DRILL KIT THAT HAD THE CORRECT 15MM DRILL GUIDE PRESENT. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) DRILL KIT FOR BME SPEED(TM) HAND AND WRIST 2.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077484 ↗