Arthrex® AR-18710-09Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.0x9mm, Cortical, Ti · 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 00888867303591), received between Apr 28, 2025 and Mar 10, 2026 — 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
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Break
ON 17-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-18710-09 CORTICAL SCREW PLACED IN THE PROXIMAL PHALANX BROKE AT THE HEAD BEFORE THE SCREW WAS FULLY SEATED FLUSH. THE ISSUE WAS DISCOVERED DURING A HAND METACARPAL ORIF PROCEDURE PERFORMED ON (B)(6) 2026. THE BROKEN SCREW REMAINED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 20-FEB-2026: THE HEAD OF THE SCREW BROKE BEFORE FINAL IMPLANTATION AND WAS COMPLETELY RETRIEVED FROM THE PATIENT. THE BODY OF THE SCREW WAS LEFT IN PLACE. THE CASE WAS COMPLETED USING ANOTHER AR-18710-09 CORTICAL SCREW. THE PROCEDURE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.
Patient problems: Foreign Body In Patient
MAUDE report 24558399 ↗MalfunctionApr 28, 2025Break; Break
ON 3/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-18710 CORTICAL SCREW HEAD BROKE OFF. THE SCREWS WERE TIGHTENED WITH 2-FINGER TIGHTNESS AND BROKE AS THE HEAD OF THE SCREW WAS MAKING CONTACT WITH THE CORTICAL BONE. THERE WAS NO PLATE USED DURING THE PROCEDURE. THE SURGEON LOCATED THE HEADS OF THE SCREWS AND WAS ABLE TO REMOVE THEM SUCCESSFULLY. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 4/24/2025.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21917264 ↗
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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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