Arthrex® AR-8725-36HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW,2.5 MICRO,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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867303270), received between Jan 23, 2025 and Jun 20, 2025 — 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
- Material Fragmentation1
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.
MalfunctionJun 20, 2025Break; Break
ON 06/02/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL AN ISSUE INVOLVING AN AR-8725-36H MICRO COMPRESSION FT DURING A DIP FUSION PROCEDURE ON (B)(6) 2025. WHILE INSERTING THE 2.5 HEADLESS COMPRESSION SCREW, THE TIP OF THE CANNULATED DRIVER BROKE WITHIN THE HEAD OF THE SCREW, AND THE DISTAL TIP OF THE SCREW FRACTURED DURING INSERTION. ADDITIONAL INFORMATION REQUESTED ON 6/18/2025.
Patient problems: Insufficient Information
MAUDE report 22298366 ↗MalfunctionJan 23, 2025Material Fragmentation; Material Fragmentation
ON 12/28/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8725-36H COMPR FT SCREW STRIPPED. THE BONE AND SCREW HAD TO BE SHORTENED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217799 ↗
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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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