Arthrex® AR-8973-14Recalls & reported problems
Arthrex, Inc. · Insertion Guide Assembly · Class 1
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 00888867302730), received between Apr 25, 2022 and Sep 16, 2024 — 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
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06652477 THAT AN AR-8973-14 INSERTION GUIDE ASSEMBLY BROKE. THIS OCCURRED DURING AN ANKLE FX - FIBULOCK PROCEDURE ON (B)(6) 2024 WHEN THE FIBULOCK IMPLANT INSERTION GUIDE BROKE RANDOMLY IN THE MIDDLE OF WITH NO SURGEON ERROR. THEY WERE STILL ABLE TO CONTINUE THE CASE WITH NO ISSUES AND NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20227398 ↗MalfunctionApr 25, 2022Break
ON 4/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973-14 IMPLANT INSERTION GUIDE BROKE OFF IN PATIENT AND WAS REMOVED. THIS WAS DISCOVERED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED WITHOUT FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 14192796 ↗
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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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