Arthrex® AR-8927BCRecalls & reported problems
Arthrex, Inc. · 4.5X14MM BC CORKSCREW FT, DX · Class 2 · Implant
Data updated Oct 16, 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 00888867131521), received between Feb 11, 2021 and Jan 26, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AR-8927BC SERIAL NO (B)(6) CORKSCREW BROKE UPON INSERTION. THIS WAS DETECTED DURING USE IN SURGICAL FIXATION RIGHT ANKLE FRACTURE PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE USE OF ANOTHER ANCHOR AND NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY.
Patient problems: Insufficient Information
MAUDE report 24176646 ↗MalfunctionFeb 11, 2021Break
IT WAS REPORTED THAT THE AR-8927BC FROM LOT: 11616289 BROKE WHILE IMPLANTING IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 11314790 ↗MalfunctionFeb 11, 2021Break
IT WAS REPORTED THAT TWO AR-8927BC FROM LOT: 11616289 BROKE IN THE SAME SPOT WHILE IMPLANTING IN THE PATIENT. THE SECOND ONE HAD A PORTION STUCK INSIDE PATIENT SO THE SURGEON USED THE NEEDLES TO DO THE REPAIR.
Patient problems: Insufficient Information
MAUDE report 11314704 ↗
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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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