Arthrex® AR-8771-0322TRecalls & reported problems
Arthrex, Inc. · DynaNite® Comp Plate, 3-Hole T, 22mm · Class 2 · Implant
Data updated Oct 18, 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 00888867339873), received between Oct 12, 2021 and Nov 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Break; Break
PRODUCT WAS IMPLANTED ON (B)(6) 2021. THE SURGEON USED A NITINOL STAPLE IN CONJUNCTION WITH THE PLATE AND FOLLOWED A CONSERVATIVE POST-OP PROTOCOL. AT 5 WEEKS THE PATIENT CAME IN FOR A FOLLOW UP AND X-RAYS SHOWED THAT THE PLATE WAS BROKEN. THE PATIENT WAS NON-WEIGHT-BEARING.
Patient problems: Failure of Implant
MAUDE report 18112494 ↗MalfunctionOct 12, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8771-0322T DYNANITE PLATE BROKE POST-OPERATIVE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2021 FOR A TMT 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 12616537 ↗
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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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