Arthrex® AR-8725-14HSRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW,2.5 MICRO,14MM LGTH, STRL · 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 00888867278493), received between Jun 18, 2024 and Jun 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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
- Manufacturing, Packaging or Shipping Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON 09/17/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8725-14HS 2.5 MICRO COMPRESSION SCREW WAS SOLID WHEN IT SHOULD HAVE BEEN HOLLOW. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED PROCEDURE PERFORMED ON (B)(6) 2021. THE CASE WAS COMPLETED USING A NEW PRODUCT WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19568520 ↗MalfunctionJun 18, 2024Material Integrity Problem; Material Integrity Problem
ON 1/06/2023, IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA EMAIL THAT AN AR-8725-14HS COMPRESSION FT SCREW HAS A GUIDE WIRE INSIDE THE SCREW. THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED UPON OPENING BOX ON (B)(6) 2022, WITH NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION RECEIVED ON 1/09/2023: STAFF NOTICED THE ISSUE BEFORE THE SURGERY. THE CASE WAS COMPLETED USING AN AR-8725-14HS COMPRESSION FT SCREW. NO PHOTOS WERE TAKEN. ADDITIONAL INFORMATION RECEIVED ON 1/12/2023: THIS WAS DISCOVERED DURING A PROCEDURE TO FIX THE FINGERS OF THE HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564001 ↗
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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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