Arthrex® AR-8771-0427XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867339903), received between Oct 11, 2021 and Jun 18, 2024 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY SURGERY ON (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY SURGERY. AR-8771-0230S (LOT: 10722395) / QTY. 1, AR-8771-0427X (LOT: 10722415) / QTY. 1, AR-8719MXDS-1818 (LOT: 0051101455) / QTY. 1. THE SURGEON PUT THE PATIENT INTO BOOT DURING WEEK 5/6. TO THE SURGEONS KNOWLEDGE THE PATIENT WAS COMPLIANT. IT WAS REPORTED THAT THERE WAS ONE DAY THE PATIENT WAS DOING HOUSE CHORES WHILE IN THE BOOT AND FELT PAIN IN THEIR FOOT AFTER STANDING FOR A LONG PERIOD OF TIME BUT CLAIMED TO HAVE NO INJURY. DURING WEEK 8/9 PATIENT CAME INTO CLINIC AND SURGEON NOTICED A CRACK IN THE AR-8771-0230S. THEN WEEK 12 CAME AROUND, AND THE SECOND PLATE AR-8771-0427X HAD BROKEN. STAPLE WAS INTACT THROUGHOUT THIS TIME FRAME. ON (B)(6) 2021, THE PATIENT CAME BACK INTO CLINIC AND X-RAY SHOWS THAT THE PROXIMAL STAPLE ARM OF AR-8719MXDS-1818 WAS BROKEN AS WELL. AS OF NOW PATIENTS PAIN LEVEL IS OKAY, AND THE SURGEON PLANS TO REMOVE HARDWARE AT ONE YEAR POST-OP. SEE SOURCE DATA AND X-RAY IMAGE ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 5/14/2021: THE REP REPORTED THE ORIGINAL PROCEDURE TYPE WAS A MIDFOOT FUSION. AT THIS TIME, THE REVISION SUR

  Patient problems: Failure of Implant

  MAUDE report 19558615 ↗
• InjuryOct 11, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8771-0422X DYNANITE COMP PLATE AND AN AR-8771-0427X DYNANITE COMP PLATE BROKE POST-OPERATIVE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A TN AND CC FUSION. THIS PROCEDURE TOOK PLACE AT ST. CLOUD HOSPITAL, ARTHREX ACCOUNT# (B)(4). DATE OF REVISION IS UNKNOWN.

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

  MAUDE report 12609029 ↗