Arthrex® AR-5025B-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867034693), received between May 3, 2022 and Jan 5, 2026 — classified as 3 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 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.

• MalfunctionJan 5, 2026Failure to Advance

  IT WAS REPORTED THAT DURING THE REFIXATION OF THE KNEE CARTILAGE, THE SCREW BROKE DURING INSERTION BECAUSE IT COULD NOT BE SCREWED IN. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957781 ↗
• MalfunctionJul 31, 2025Defective Device; Defective Device

  ON 07/08/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-5025B-18 BIO-COMPRESSION SCREW CAME OUT OF THE PACKAGE WITH A CRACK IN IT. UPON ATTEMPTING INSERTION, THE SCREW BROKE FURTHER AND WAS IMMEDIATELY REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED USING ANOTHER AR-5025B-18 BIO-COMPRESSION SCREW FROM THE SAME LOT. THE CASE WAS DELAYED MINIMALLY, AND THE PATIENT WAS NOT HARMED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/15/2025: THIS ISSUE WAS DISCOVERED DURING A CARTILAGE REPAIR PROCEDURE ON (B)(6)2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675273 ↗
• MalfunctionMay 3, 2022Break

  IT WAS REPORTED THAT DURING AN OCD REPAIR SURGERY THE BIO-COMPRESSION SCREWS BROKE WHILE INSERTING. THE FIRST ONE BROKE ABOUT 4MM TO COMPLETE THE INSERTION. THE SECOND ONE BROKE WITH HALF OF THE SCREW OUTSIDE THE BONE. THE TUNNEL WAS DRILLED WITH THE CORRECT DRILL SIZE AND TAP. APPARENTLY THE SCREW WAS BEING INTRODUCED IN THE CORRECT DIRECTION. THE BROKEN PART REMAINS IN PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH CHONDRAL DARTS AR-4005B-18. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14269636 ↗