Arthrex® AR-5025B-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867034716), received between Aug 11, 2016 and Feb 27, 2023 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-5025B-22 BIO-COMPRESSION SCREW,3.0MM BY 22MM, AND AN AR-5025B-26 BIO-COMPRESSION SCREW, 3.0MM BY 26MM, SNAPPED IN HALF DURING INSERTION. CASE WAS COMPLETED BY USING A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444469 ↗
• InjuryAug 11, 2016Break

  IT WAS REPORTED THAT DURING AN OCD LESION MICRO-FRACTURE PROCEDURE THE SURGEON USED THE K-WIRE, PREDRILLED AND PRE-TAPPED. HALFWAY THROUGH INSERTION, THE IMPLANT AR-5025B-24 LOT 10042879 ((B)(4)) BROKE. THE SCREW WAS REMOVED BUT FRAGMENTS REMAINED IN THE PATIENT. THE SURGEON TRIED A SECOND SMALLER IMPLANT AR-5025B-22 LOT 10033308 ((B)(4)) AND THE SAME ISSUE OCCURRED, LEAVING FRAGMENTS IN THE PATIENT. A THIRD SMALLER IMPLANT AR-5025B-20 LOT 1217167 ((B)(4)) WAS ATTEMPTED AND THIS ONE ABOUT 1/4 OF THE WAY DOWN THE THREADS BEGAN TO COMPRESS AND SURGEON CHOSE TO REMOVE THE SCREW WHILE STILL WHOLE. THE SURGEON COMPLETED THE CASE WITH K-WIRES. PATIENT WAS A (B)(6) FEMALE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5868146 ↗