Arthrex® AR-8943-21Recalls & reported problems
Arthrex, Inc. · SHARP HOOK · Class 1
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 00888867052314), received between May 3, 2021 and May 3, 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
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2021Break
IT WAS REPORTED DURING A CASE THE SURGEON INSERTED THE SCREW THEN THE HEAD OF THE DRIVER SNAPPED OFF IN SCREW. THE SURGEON USED THE DENTAL PICK TO GET THE DRIVER SHAFT OUT OF THE HEADLESS SCREW AND THE PICK BROKE. ALL WAS RETRIEVED. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE. THE CASE WAS AN ORIF OF 3RD AND 4TH METACARPAL.
Patient problems: Insufficient Information
MAUDE report 11761489 ↗
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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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