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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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