Arthrex® AR-8719DS-1515Recalls & reported problems
Arthrex, Inc. · Dynanite NiTi Staple w/Instrs 15Wx15L · 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 00888867288126), received between May 24, 2024 and Feb 3, 2026 — classified as 2 malfunctions.
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
- Fitting Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Break
ON 13-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8719DS-1515 DYNANITE NITINOL STAPLE IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING IMPLANTATION. THE STAPLE WAS PARTIALLY INSERTED A FEW MILLIMETERS INTO THE BONE BEFORE IT FELL OFF THE INSERTER. WHEN ATTEMPTING TO RELOAD THE STAPLE, THE TINES OF THE INSERTER REPEATEDLY POPPED OFF THE STAPLE AS THEY ATTEMPTED TO SPREAD THE LEGS. THE STAPLE COULD NOT BE RELOADED AND WAS UNABLE TO BE IMPLANTED. THIS ISSUE WAS DISCOVERED DURING A COTTON OSTEOTOMY PROCEDURE PERFORMED ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 16-JAN-2026: ALL FRAGMENTS WERE RETRIEVED. AN ADDITIONAL AR-8719DS-1515 DYNANITE NITINOL STAPLE IMPLANT SYSTEM OF THE SAME SIZE WAS OPENED AND IMPLANTED WITHOUT ISSUE. THE CASE WAS DELAYED APPROXIMATELY 4 MINUTES, WITH NO ADDITIONAL ANESTHESIA REPORTED FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24248684 ↗MalfunctionMay 24, 2024Fitting Problem; Fitting Problem
ON 10/27/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8719DS-1515 STAPLE IMPLANT SYSTEM CANNOT BE FITTED. THE STAPLE AND THE DEVICE CAN NOT BE FITTED. A NEW DEVICE WAS USED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 10/28/2021: THE HOOK PART OF THE DEVICE DID NOT FIT THE STAPLE AND COULD NOT BE ATTACHED. PROCEDURE BEING PERFORMED WAS HALLUX VALGUS DISTAL OSTEOTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392458 ↗
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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