Arthrex® AR-1595Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867019881), received between May 31, 2022 and Apr 8, 2024 — 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 16, 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.

• MalfunctionApr 8, 2024Break; Break

  ON 03/18/2024, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1595 RETRO BUTTON DRILL TIP WAS BROKEN WHEN CREATING A FEMORAL FORAMEN USING THE TP TECHNIQUE. THE TIP COULD BE REMOVED FROM INSIDE THE JOINT BY CUTTING THE FORAMEN USING AN EICH OR MOSQUITO. USED A NEW PRODUCT AND THE CASE IS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 19067364 ↗
• MalfunctionMay 31, 2022Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGERY AFTER THE SURGEON USED THE RETROBUTTON DRILL PIN, IT WAS NOTICED THAT THERE WAS SMALL METAL DEBRIS AROUND IT AT THE LEVEL OF THE ARTHROSCOPY IMAGE. THE SURGEON PERFORMED A SUCTION AND WASH OF THE SURGICAL SITE TO REMOVE THE DEBRIS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14548030 ↗