Arthrex® AR-8973R-38-180Recalls & reported problems
Arthrex, Inc. · 3.8X180MM FIBULA NAIL, RIGHT · Class 2 · Implant
Data updated Oct 18, 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 00888867295278), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
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.
MalfunctionOct 25, 2023Defective Device; Defective Device
ON 9/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973R-38-180 ARTHREX FIBULOCK NAIL TALONS DID NOT DEPLOY AND THE ACTIVATION DRIVER WAS NOT SEATING ALL THE WAY. THE SURGEON REMOVED THE ARTHREX FIBULOCK NAIL AND ATTEMPTED TO ACTIVATE THE TALONS OFF THE JIG BUT WAS UNSUCCESSFUL. ANOTHER AR-8973R-38-180 ARTHREX FIBULOCK NAIL WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A FIBULOCK NAIL PROCEDURE ON 9/26/2023. AFTER THE PROCEDURE, THE SALES REPRESENTATIVE PUT THE FIBULOCK NAIL THROUGH THE WASH AND SPENT ABOUT TEN TO FIFTEEN MINUTES TRYING TO DEPLOY THE TALONS. ONCE THE TALONS HAD DEPLOYED, THE SALES REPRESENTATIVE NOTICED THAT THERE WAS A SMALL GRAY BAR OR LEDGE INTERFERING WITH THE DRIVER.
Patient problems: Insufficient Information
MAUDE report 18005378 ↗
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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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