Arthrex® AR-8725-26HRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867126916), received between Sep 19, 2016 and Dec 27, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA PHONE, THAT AN AR-8725-26H MICRO COMPRESSION FT DE-THREADED DURING INSERTION AND FRAGMENTS BROKE OFF THE SCREW. ONE OF THE METAL SHAVINGS COULD NOT BE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY REMOVING THE SCREW AND USING A NEW AR-8725-26H MICRO COMPRESSION FT. THIS WAS DISCOVERED DURING A PIP HAMMERTOE PROCEDURE ON (B)(6)2024. THE CASE WAS NOT DELAYED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21027203 ↗
• InjuryJul 16, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIPJ FUSION OF THE INDEX FINGER, THE SURGEON WAS ATTEMPTING TO INSERT A 2.5 MICRO COMPRESSION SCREW, (B)(4), ONE OF THE CUTTING FLUTES BROKE OFF OF THE DISTAL END OF THE SCREW. THE SURGEON USED A DOUBLE ENDED K-WIRE AND A PROFILE DRILL FOR MICRO HCS AND A 2.0 DRILL BIT TO A DEPTH OF 24MM TO PREPARE THE BONE. THE SMALL CUTTING FLUTE WAS LODGED IN THE CANAL OF THE PROXIMAL PHALANX OF THE INDEX FINGER AND COULD NOT BE RETRIEVED, HOWEVER, THE SURGEON WAS NOT CONCERNED OF THE PIECE FLOATING AROUND. ADDITIONAL INFORMATION OBTAINED. THE CASE WAS COMPLETED JUST AS PLANNED. THE SURGEON USED A SECOND 2.5 MICRO HCS AND PLACED IT OVER THE BROKEN HCS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7691730 ↗
• InjurySep 19, 2016Break

  IT WAS REPORTED THAT DURING A DISTAL INTERPHALANGEAL JOINT FINGER PROCEDURE THE COMPRESSION SCREW BROKE ON INSERTION. THE SURGEON BACKED OUT THE LOOSE BROKEN PIECE OF THE COMPRESSION SCREW AND REMOVED IT FROM THE PATIENT. THE SURGEON MADE THE DECISION THAT THE PARTIAL PART OF THE SCREW THAT WAS INSERTED WAS SECURE ENOUGH TO COMPLETE THE CASE WITHOUT ADDITIONAL IMPLANTATION. LOOSE PIECE THAT WAS RETRIEVED WAS DISCARDED BY THE FACILITY. SURGEON HAD DRILLED WITH A 2.0 CANNULATED DRILL, FOLLOWED BY THE MICRO COMPRESSION FT PROFILE DRILL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5960132 ↗