Arthrex® AR-18716-08Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.6 x 8mm, Cortical · 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 00888867313200), received between Nov 30, 2021 and Nov 30, 2021 — 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.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2021Break
ON 11/12/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-08, AN AR-18716-09, AND AN AR-18716-11 CORTICAL SCREWS BROKE ON THE FILE TIGHTENING OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED. AFTER RECEIVING ADDITIONAL INFORMATION ON 11/12/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING THE METACARPAL FRACTURE PROCEDURE, THREE CORTICAL SCREW BROKE AND REMAINED IN PATIENT. SURGEON USED A 1.2MM DRILL BIT TO PREPARE BONE TUNNELS AND PUT IN NEW SCREWS IN OTHER HOLES OF THE PLATE.
Patient problems: Foreign Body In Patient
MAUDE report 12897434 ↗
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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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