Arthrex® AR-8725-34HRecalls & reported problems
Arthrex, Inc. · COMPR FT SCRW,2.5 MICRO,34MM LGTH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867303263), received between Jun 30, 2020 and Jun 30, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2020Break
IT WAS REPORTED DURING A INTERPHALANGEAL JOINT FUSION PROCEDURE UPON INSERTING THE 2.5. X 34MM HEADLESS COMPRESSION SCREW THE AR-8737-37, 1.5 MM HEX CANNULATED DRIVER SHAFT SNAPPED OFF IN THE HEAD OF THE SCREW. THE BROKEN DRIVER TIP WAS REMOVED BY USING PLIERS. THE SURGEON DECIDED TO LEAVE THE SCREW IN THE DISTAL ASPECT OF THE 1ST METATARSAL BECAUSE IT WAS NOT IN THE JOINT. THERE WERE NOT ANY UNPLANNED INCISIONS MADE OTHER THAN THE INCISION TO USE A LARGER SCREW 3.5 HEADLESS COMPRESSION SCREW TO COMPLETE THE JOINT FUSION. EE SOURCE DATA ATTACHED. ADDITIONAL INFORMATION OBTAINED 06/10/2020: THE ARTHREX 2.5 X 34MM HEADLESS COMPRESSION SCREW (AR-8725-34H) WAS IMPLANTED INTO THE DISTAL ASPECT OF THE 1ST METATARSAL HEAD. THE SCREW WAS SUPPOSED TO GO FROM THE DISTAL ASPECT OF THE 1ST METATARSAL HEAD, ADVANCING TO FUSE THE INTERPHALANGEAL JOINT TOGETHER. THE SCREW WAS NOT PROTRUDING INTO THE JOINT SO THE SURGEON MADE THE DECISION TO LEAVE IT IN THE DISTAL ASPECT OF THE 1ST METATARSAL HEAD. SURGEON THEN MADE A SEPARATE INCISION TO INSERT A 3.5 X 36MM HEADLESS COMPRESSION SCREW IN ORDER TO COMPLETE THE IPJ FUSION, WHICH WAS SUCCESSFUL. THE AR-8737-37, HEX DRIVER IS BEING RETURNED FOR EVALUA
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10212049 ↗
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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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