Arthrex® AR-8719MXDS-1515Recalls & reported problems
Arthrex, Inc. · SuperMX NiTi Staple w/ Instrs, 15W x 15L · 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 00888867300866), received between Jan 16, 2025 and May 28, 2025 — 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
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Break
ON 05/08/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8719MXDS-1515 DYNANITE SUPERMX NITINOL STAPLE WITH INSTRUMENTATION ENCOUNTERED AN ISSUE WHEN USING THE SUPERMX STAPLE DRILL BIT. THE DRILL BIT BROKE OFF INSIDE THE PATIENT. THE SURGEON SUCCESSFULLY REMOVED THE DRILL BIT, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT, AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A REVISION TALONAVICULAR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096621 ↗MalfunctionJan 16, 2025Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL FROM AN AR-8719MXDS-1515 DYNANITE SUPERMX NITINOL STAPLE WOULD NOT ADVANCE THROUGH THE GUIDE. THE SURGEON STOPPED DRILLING AND NOTED THAT THE DRILL AND GUIDE COULD NOT BE TAKEN APART. THE GUIDE ENDED UP BREAKING IN HALF AND THE DRILL WAS STILL INSIDE THE GUIDE. THIS WAS DISCOVERED DURING A SECOND AND THIRD TARSOMETATARSAL ARTHRODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 1/6/2025: THE GUIDE BROKE WHILE IT WAS IN THE PATIENT; HOWEVER, THERE WERE NO LOOSE FRAGMENTS IN THE PATIENT AND THE SURGEON WAS ABLE TO REMOVE THE BROKEN DRILL GUIDE AND BIT SAFELY. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-8719MXDS-1515 DYNANITE SUPERMX NITINOL STAPLE. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168160 ↗
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- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
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- 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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