Arthrex® AR-8740-36HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW,4.0 STD,36MM LGTH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867127746), received between Aug 3, 2021 and Jun 21, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
Patient problems
- Pain2
- Hypersensitivity/Allergic reaction1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 5/22/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT A POST-MARKET CLINICAL STUDY WAS PERFORMED FOR A CLINICAL OUTCOME OF MIDFOOT ARTHRODESIS USING THE ARTHREX DYNANITE STAPLE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH AN AR-8719MXDS-2520 DYNANITE SUPERMX NITINOL STAPLE AND AN AR-8740-36H STANDARD COMPRESSION FT WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH BREAKTHROUGH PAIN IN THE LEFT LEG AND FOOT. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2021, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT AGAIN AND STATED THAT IT EXACERBATED THE UNDERLYING PAIN. THE PATIENT WAS NOT ADMITTED AND DID NOT CAUSE ANY INJURY TO THE RIGHT FOOT. ADDITIONAL INFORMATION RECEIVED ON 6/4/2024: THE PATIENT WAS LAST SEEN BY THE SURGEON ON (B)(6) 2021 AND WAS REPORTING PAIN EIGHT OUT OF TEN. THE PATIENT HAS BEEN SEEN AT THE OFFICE FOR OTHER ISSUES, BUT NONE RELATED TO THE LEFT FOOT SURGERY.
Patient problems: Pain
MAUDE report 19582487 ↗InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AFTER 12 WEEKS POST OP FROM BUNION SURGERY ON (B)(6) 2021 THE PATIENT IS EXPERIENCING SWELLING. THREE SCREWS WERE IMPLANTED AND THE PATIENT FEELS SHE COULD BE HAVING AN ALLERGIC REACTION. THE PATIENT WAS IN A HARD CAST FOR THE FIRST 30 DAYS THEN TO A WALKING BOOT AT THE 4TH WEEK. DURING THE TIME RIGHT AFTER THE CAST REMOVAL HER FOOT BECAME QUITE SWOLLEN AND SHE EXPERIENCED MORE THAN A MODERATE AMOUNT OF PAIN. THE PATIENT ELEVATED AND ICED THE FOOT WHICH RELIEVED THE PAIN TO A TOLERABLE AMOUNT BUT THE SWELLING NEVER WENT AWAY. THE PATIENT IS CONCERNED SHE HAS A SENSITIVITY TO METAL WHICH COULD BE CAUSING THIS ISSUE.
Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema
MAUDE report 12267207 ↗
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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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