Arthrex® AR-8771-0425SRecalls & reported problems
Arthrex, Inc. · DynaNite® Comp Plate, 4-Hole STR, 25mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867308022), received between Oct 11, 2021 and Mar 7, 2024 — classified as 2 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2024Break; Break
ON 21ST FEB 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8771-0425S, DYNANITE® COMP PLATE, 4-HOLE STR, 25MM, SNAPPED. THIS OCCURRED ON (B)(6) 2024, DURING 1, 2, 3RD TMT FUSION L FOOT PROCEDURE, WHILE BEING IMPLANTED. BROKEN PLATE WAS REMOVED AND PROCEDURE WAS COMPLETED SUCCESSFULLY BY IMPLANTING A NEW ONE INSTEAD.
Patient problems: Insufficient Information
MAUDE report 18858069 ↗InjuryOct 11, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8771-0425S DYNANITE PLATE BROKE POST-OPERATIVE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A MTP FUSION. THIS PROCEDURE TOOK PLACE AT UNITED SAME DAY SURGERY CENTER, ARTHREX ACCOUNT #(B)(4). DATE OF REVISION IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12608934 ↗InjuryOct 11, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8771-0430S DYNANITE PLATE BROKE POST-OPERATIVE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A MTP FUSION. THIS PROCEDURE TOOK PLACE AT UNITED SAME DAY SURGERY CENTER, ARTHREX ACCOUNT # (B)(4). DATE OF REVISION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12608753 ↗
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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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