Arthrex® AR-8719DS-2520Recalls & reported problems
Arthrex, Inc. · Dynanite NiTi Staple w/Instrs 25Wx20L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867288171), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2020Break
IT WAS REPORTED THAT THE CLAMP BROKE POSTOPERATIVE. UPDATED INFORMATION 10-FEB-2020: IT WAS FURTHER REPORTED THAT THE CLAMP MOST LIKELY BROKE DURING THE PROCESSING AFTER THE SURGERY. UPDATED INFORMATION 07-APR-2020: FURTHER INFORMATION WAS PROVIDED THAT THE ARTICLE BROKE INSIDE THE PATIENT. THEREFORE AN ADDITIONAL SURGERY NEEDED TO BE PERFORMED. IT WAS FURTHER REPORTED THAT THE INITIAL SURGERY WAS A TN-FUSION AND IT WAS PERFORMED ON (B)(6) 2019. THE REVISION WAS PERFORMED ON (B)(6) 2020. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IN ADDITION A SCREW WAS USED.
Patient problems: No Code Available
MAUDE report 10009079 ↗
Other Staple, fixation, bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- 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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