DARCO DC4212Recalls & reported problems
Wright Medical Technology, Inc. · Temp Fixation K-Wire · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420192226), received between Nov 22, 2022 and Dec 5, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 16, 2026.
Most reported problems
Device problems
- Device Difficult to Setup or Prepare2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED THERE WAS A PROBLEM WITH THE BALL OF THE PLATE FIXING PINS IS TOO SMALL AND IT PASSED INSIDE THE PLATE HOLE, NOT PERFORMING ITS FUNCTION OF FIXING IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.
Patient problems: Insufficient Information
MAUDE report 15915941 ↗MalfunctionNov 22, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
IT WAS REPORTED THERE WAS A PROBLEM WITH THE BALL OF THE PLATE FIXING PINS IS TOO SMALL AND IT PASSED INSIDE THE PLATE HOLE, NOT PERFORMING ITS FUNCTION OF FIXING IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.
Patient problems: Insufficient Information
MAUDE report 15844892 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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