Arthrex® AR-8625-16Recalls & reported problems
Arthrex, Inc. · HEADLESS COMPRES SCRW 2.5X16MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867125612), received between Jan 14, 2025 and Jan 14, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Break; Break
ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8625-16 HEADLESS COMPRESSION SCREW TIP BROKE DURING INSERTION. WHEN THE SCREW WAS PLACED AND COMPRESSED, THE SURGEON NOTICED IT WAS NOT COMPRESSING AND FOUND THE TIP BROKEN. THIS WAS DISCOVERED DURING A BUNION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025. THE SALES REPRESENTATIVE IS UNSURE IF ALL BROKEN FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER HEADLESS COMPRESSION SCREW FROM THE SAME TRAY, BUT THE SIZE OF THE SCREW IS UNKNOWN. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: Insufficient Information
MAUDE report 21148950 ↗
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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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