Arthrex® AR-9928BCRecalls & reported problems
Arthrex, Inc. · 3.9MM BC SWIVELOCK W FLAG · 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 00888867389588), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
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.
MalfunctionFeb 26, 2025Material Deformation; Material Deformation
ON 02/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9928BC AR-9928BC 3.9MM BC SWIVELOCK W FLAGS SCREW WAS STRIPPING. THIS EVENT OCCURRED DURING AN ACHILLES PROCEDURE ON (B)(6) 2025 WHEN THE SCREW STARTED STRIPPING UPON INSERTION. EVERYTHING WAS REMOVED FROM THE PATIENT. THEY PROCEEDED TO REDRILL FOR THE NEXT SIZE UP. A TAP WAS USED TO PREPARE THE BONE. THE PATIENT HAD A DECENT BONE QUALITY.
Patient problems: Insufficient Information
MAUDE report 21470737 ↗
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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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