Arthrex® AR-8719MXDS-1818Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867300880), received between Dec 20, 2019 and Jun 3, 2024 — classified as 3 injuries, 3 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT A POST-MARKET CLINICAL STUDY WAS PERFORMED FOR A CLINICAL OUTCOME OF MIDFOOT ARTHRODESIS USING THE ARTHREX DYNANITE STAPLE. ON (B)(6) 2021, A PATIENT UNDERWENT SURGERY IN WHICH TWO AR-8719MXDS-1818 DYNANITE SUPERMX NITINOL STAPLE WAS IMPLANTED. THE PATIENT PRESENTED WITH PAIN AND IS SCHEDULED TO UNDERGO REVISION SURGERY ON (B)(6) 2024 . NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Pain

  MAUDE report 19446923 ↗
• InjuryJun 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED ON 5/22/2024: THE FACILITY REPRESENTATIVE MADE A MISTAKE IN THE REVISION SURGERY. THE PATIENT UNDERWENT THE ORIGINAL SURGERY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING ON THE DORSAL ASPECT OF THE MIDFOOT, LEADING TO A REVISION SURGERY ON (B)(6) 2021. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON. ADDITIONAL INFORMATION RECEIVED ON 6/4/2024: DURING THE REVISION SURGERY, THERE WERE NO ARTHREX PRODUCTS EXPLANTED, OR NEW ONES IMPLANTED.

  Patient problems: Pain

  MAUDE report 19446893 ↗
• MalfunctionDec 4, 2023Break; 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 SURGE

  Patient problems: Failure of Implant

  MAUDE report 18255231 ↗
• MalfunctionMar 15, 2021Break

  IT WAS REPORTED BY A PATIENT THAT TWO ARTHREX STAPLES HAD BEEN USED DURING HER FOOT SURGERY. ONE STAPLE HAS BEEN FOUND TO BE BROKEN. PATIENT STATES THAT THE SURGEON DOES NOT APPEAR TO BE VERY CONCERNED ABOUT THE BROKEN DEVICE. SPECIFIC ARTHREX PART NUMBER WAS NOT PROVIDED AT TIME OF INITIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11484813 ↗
• MalfunctionMar 15, 2021Break

  IT WAS REPORTED BY A PATIENT THAT TWO ARTHREX STAPLES HAD BEEN USED DURING HER FOOT SURGERY. ONE STAPLE HAS BEEN FOUND TO BE BROKEN. PATIENT STATES THAT THE SURGEON DOES NOT APPEAR TO BE VERY CONCERNED ABOUT THE BROKEN DEVICE. SPECIFIC ARTHREX PART NUMBER WAS NOT PROVIDED AT TIME OF INITIAL REPORT.

  Patient problems: Failure of Implant

  MAUDE report 11483957 ↗
• InjuryDec 20, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED AFTER FOOT RECONSTRUCTION PROCEDURE ARTHROCELL WAS USED. THE PATIENT HAD AN ADVERSE REACTION INCLUDING FEVER SPIKES ONE DAY POST-OP. THERE WERE ALSO FOUR SCREWS AND TWO STAPLES IMPLANTED. NO REVISION IS PLANNED AT THIS TIME. CURRENTLY THE DOCTOR IS RESEARCHING THE SOURCE OF THE REACTION.

  Patient problems: Fever

  MAUDE report 9506161 ↗