Arthrex® AR-8719MXDS-2520Recalls & reported problems
Arthrex, Inc. · SuperMX NiTi Staple w/ Instrs, 25W x 20L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867300910), received between Jun 3, 2024 and Jun 21, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Patient Device Interaction Problem1
Patient problems
- Pain2
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 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. THE PATIENT UNDERWENT A PROCEDURE IN WHICH AN AR-8719MXDS-2520 DYNANITE SUPERMX NITINOL STAPLE AND AN AR-8740-36H STANDARD COMPRESSION FT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH BREAKTHROUGH PAIN IN THE LEFT LEG AND FOOT. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2021, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT AGAIN AND STATED THAT IT EXACERBATED THE UNDERLYING PAIN. THE PATIENT WAS NOT ADMITTED AND DID NOT CAUSE ANY INJURY TO THE RIGHT FOOT. ADDITIONAL INFORMATION RECEIVED ON 6/4/2024: THE PATIENT WAS LAST SEEN BY THE SURGEON ON (B)(6) 2021 AND WAS REPORTING PAIN EIGHT OUT OF TEN. THE PATIENT HAS BEEN SEEN AT THE OFFICE FOR OTHER ISSUES, BUT NONE RELATED TO THE LEFT FOOT SURGERY.
Patient problems: Pain
MAUDE report 19582441 ↗InjuryJun 3, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED ON 5/22/2024: THE ORIGINAL SURGERY DATE WAS ON (B)(6) 2020. THE PATIENT UNDERWENT REVISION SURGERY FOR A POSSIBLE ALLERGIC REACTION TO THE NICKEL IN THE ARTHREX DYNANITE STAPLE. AT THIS TIME, IT IS UNKNOWN WHICH PRODUCTS WERE EXPLANTED, PER THE FACILITY REPRESENTATIVE, IT WAS NOT DOCUMENTED IN THE OPERATIVE REPORT NOTES. THE SAME SURGEON PERFORMED BOTH SURGERIES.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 19447028 ↗
Other Staple, fixation, bone devices
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- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
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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