Arthrex® AR-18716-15Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.6 x 15mm, Cortical · Class 2 · Implant
Data updated Oct 18, 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 00888867313279), received between Dec 27, 2021 and Sep 10, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721098 ↗MalfunctionOct 6, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-15 LOW PROFILE SCREW HEAD SNAPPED OFF DURING INSERTION. THE BODY OF THE SCREW REMAINS IMPLANTED, AND THE BROKEN HEAD WAS SUCCESSFULLY REMOVED. THE SURGEON WAS USING A JEWELER'S SCREWDRIVER WHEN THE HEAD OF THE SCREW SNAPPED OFF. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2023.
Patient problems: Foreign Body In Patient
MAUDE report 17884684 ↗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: Insufficient Information
MAUDE report 13087507 ↗
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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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