Arthrex® AR-8943H-03Recalls & reported problems
Arthrex, Inc. · LOCKING MEDIAL HOOK PLATE, SS, 3H · Class 2 · Implant
Data updated Oct 18, 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 00888867052703), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
ON 1/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8943H-03 LOCKING DELTOID AVULSION PLATE DISTAL HOLES WERE OFF CENTER AND APPEARED TO BE DAMAGED. SURGEON WAS UNABLE TO SCREW THE LOCKING GUIDE INTO THE PLATE AS IT KEPT CROSS THREADING. THIS WAS DISCOVERED DURING A TALUS OATS PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 1/9/2023: CASE WAS COMPLETED USING ANOTHER AR-8943H-03 LOCKING DELTOID AVULSION PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19485820 ↗
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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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