Arthrex® AR-4154PS-3010Recalls & reported problems
Arthrex, Inc. · 2.5 X 30MM PIP DART, PEEK, 10 DEGREE · Class 2 · Implant
Data updated Oct 18, 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 00888867242401), received between Sep 18, 2024 and Sep 18, 2024 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Break; Break
ON 09/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-4154PS-3010 PIP DARTS BROKE. THIS OCCURRED DURING A HAMMERTOES PROCEDURE ON (B)(6) 2024 EACH TIME THE JOINT WAS PREPPED AND ATTEMPTED TO INSERT THE ANCHOR IT BROKE OFF, THIS OCCURRED WITH BOTH DEVICES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT HAD A DECENT BONE QUALITY, THAT WAS PREPPER USING THE DRILL IN THE KIT. THE CASE PROCEEDED USING DIFFERENT SCREWS. THE CASE TOOK LONGER, BUT THE REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246472 ↗MalfunctionSep 18, 2024Break; Break
ON 09/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-4154PS-3010 PIP DARTS BROKE. THIS OCCURRED DURING A HAMMERTOES PROCEDURE ON (B)(6) 2024 EACH TIME THE JOINT WAS PREPPED AND ATTEMPTED TO INSERT THE ANCHOR IT BROKE OFF, THIS OCCURRED WITH BOTH DEVICES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT HAD A DECENT BONE QUALITY, THAT WAS PREPPED USING THE DRILL IN THE KIT. THE CASE PROCEEDED USING DIFFERENT SCREWS. THE CASE TOOK LONGER, BUT THE REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246429 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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