Arthrex® AR-8718DS-1310Recalls & reported problems
Arthrex, Inc. · Dynanite NiTi Staple w/Instrs 13Wx10L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867288096), received between Nov 8, 2024 and Apr 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 03/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (QTY. 2) OF AN AR-8718DS-1310 DYNANITE NITINOL STAPLE IMPLANT SYSTEM HAD AN ISSUE WITH THE PARALLEL DRILL GUIDE IN THE KIT WHEN ATTEMPTING TO DRILL THROUGH THE DRILL GUIDE TO CREATE A BONE HOLE. THE DRILL GOT STUCK IN THE GUIDE. THE CASE WAS COMPLETED USING ANOTHER AR-8718DS-1310 DYNANITE NITINOL STAPLE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A HALLUX VALGUS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/21/2025: NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS NOT DELAYED AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774848 ↗MalfunctionApr 4, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 03/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT (QTY. 2) OF AN AR-8718DS-1310 DYNANITE NITINOL STAPLE IMPLANT SYSTEM HAD AN ISSUE WITH THE PARALLEL DRILL GUIDE IN THE KIT WHEN ATTEMPTING TO DRILL THROUGH THE DRILL GUIDE TO CREATE A BONE HOLE. THE DRILL GOT STUCK IN THE GUIDE. THE CASE WAS COMPLETED USING ANOTHER AR-8718DS-1310 DYNANITE NITINOL STAPLE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A HALLUX VALGUS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/21/2025: NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS NOT DELAYED AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21774639 ↗MalfunctionNov 8, 2024Break; Break
IT WAS REPORTED THAT DURING A SCAPHOLUNATE FUSION SURGERY THE DRILL STUCK AND BROKE IN THE DRILL GUIDE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20641257 ↗
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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