Arthrex® AR-8943DL-08Recalls & reported problems
Arthrex, Inc. · LOCK DISTAL FIBULA PLT, SS LT, 8H · Class 2 · Implant
Data updated Oct 16, 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 00888867346772), received between Oct 15, 2025 and Oct 15, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device2
- Positioning Failure2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device
ON 10/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 2.7 SCREW WOULD NOT LOCK INTO AN AR-8943DL-08 LOCKING DISTAL FIBULA PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/8/2025: IT WAS CONFIRMED THAT THE 2.7 SCREW DID NOT LOCK INTO THREE AR-8943DL-08 LOCKING DISTAL FIBULA PLATE DURING THE ANKLE FIXATION SURGERY. WHEN THE PLATES WERE INSPECTED, THEY DID NOT HAVE A STAMP LIKE THE OTHER PLATES OF DIFFERENT SIZE. THE CASE WAS COMPLETED USING A 10 HOLE TUBULAR PLATE.
Patient problems: Insufficient Information
MAUDE report 23293174 ↗MalfunctionOct 15, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device
ON 10/3/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 2.7 SCREW WOULD NOT LOCK INTO AN AR-8943DL-08 LOCKING DISTAL FIBULA PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/8/2025: IT WAS CONFIRMED THAT THE 2.7 SCREW DID NOT LOCK INTO THREE AR-8943DL-08 LOCKING DISTAL FIBULA PLATE DURING THE ANKLE FIXATION SURGERY. WHEN THE PLATES WERE INSPECTED, THEY DID NOT HAVE A STAMP LIKE THE OTHER PLATES OF DIFFERENT SIZE. THE CASE WAS COMPLETED USING A 10 HOLE TUBULAR PLATE.
Patient problems: Insufficient Information
MAUDE report 23292520 ↗
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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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