Arthrex® AR-18716-10Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.6 x 10mm, Cortical · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867313224), received between Dec 27, 2021 and Sep 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18716-11 AND A AR-18716-10 LOW PROFILE SCREWS BROKE WHILE BEING IMPLANTED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004634 ↗MalfunctionJul 14, 2023Break; Break
ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE HEAD FROM AN AR-18716-10 LOW PROFILE CORTICAL SCREW BROKE OFF. THE SURGEON REMOVED ALL THE BROKEN FRAGMENTS AND USED A NEW ONE TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6)2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17329648 ↗MalfunctionDec 27, 2021Break
ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING A FOOT REPAIR TWO AR-18716-10 SCREW HEADS AND ONE AR-18716-15 BROKE OFF DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED BUT THE SCREWS REMAINED IN THE PATIENT HOLDING THE PLATE AMONG THE OTHER SCREWS. THE DOCTOR DETERMINED THE FIXATION WAS SUFFICIENT. THE PATIENT IS FINE TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13087499 ↗
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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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