Arthrex® AR-8771-0220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867307957), received between Oct 11, 2021 and Sep 26, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT QTY. 7 TO 8 AR-8771-0220S DYNANITE COMP PLATES HAVE BROKEN IN PEDIATRIC PATIENTS RECEIVING FOOT FUSIONS PROCEDURES, WHICH WE HAVE BEEN REMOVED OVER THE COURSE OF THE PAST MONTH OR SO. THIS WAS DISCOVERED AFTER USE IN VARIOUS CASES WITH DIFFERENT SURGEONS. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15484275 ↗
• MalfunctionOct 12, 2021Break

  ON 09/21/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A SURGEON IMPLANTED THREE DYNANITE COMPRESSION PLATES IN A PATIENT ON (B)(6) 2020 AND THE SAME PATIENT CAME BACK TO THE SURGEON IN (B)(6) WITH ALL THREE PLATES BROKEN. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 09/24/2021: THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A MIDFOOT FUSION. THIS PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL, ARTHREX ACCOUNT # (B)(4). LATE (B)(6) 2020 THE SURGEON PERFORMED A REVISION WHERE THE FOLLOWING ARTHREX DEVICE(S) WERE EXPLANTED. X-RAY ATTACHED. AR-8771-2020MS, LOT: 10722480 QTY. 1, AR-8771-0220S, LOT: 10722375 QTY. 2.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12616882 ↗
• InjuryOct 11, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-8771-0220S 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 12608965 ↗
• InjuryOct 11, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (2) AR-8771-0220S 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 12608920 ↗