Arthrex® AR-4211-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867033511), received between May 9, 2025 and May 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 2ND MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4211-16, PROSTOP¿ SUBTALAR ARTHROEREISIS IMPLANT, 11 X 16 MM, WAS EXPIRED. ON 4TH APRIL 2025, AN ARTHREX EMPLOYEE RECEIVED AN EMAIL FROM THE LEVEL 2 NURSE AT THE HOSPITAL ORDERING A GEAR FOR A CASE ON (B)(6) 2025. IT WAS FOR A CALC OSTEOTOMY WITH TENDON TRANSFER PROCEDURE. THE APPROPRIATE GEAR WAS SENT IN THAT WAS REQUESTED FOR THE PATHOLOGY BOOKED. WHILST DISCUSSING THE CASE WITH THE SURGEON, THEY WERE TOLD THAT IT WAS AN ARTHROEREISIS SCREW AND NOT AN ARTHRODESIS SCREW, WHICH WAS BOOKED. THE PATIENT WAS ON THE TABLE AT THIS STAGE AND UNDER ANESTHESIA. THE ARTHREX EMPLOYEE CLARIFIED THAT THE CORRECT SCREW WAS SENT BASED ON THE ORIGINAL BOOKING MADE BY THE HOSPITAL. HOWEVER, THE SURGEON WANTED TO DO A DIFFERENT PROCEDURE WHICH REQUIRED A DIFFERENT SCREW WHICH WAS NOT SENT IN AND THEY WERE ONLY MADE AWARE WHEN THE PATIENT WAS IN THE OPERATING ROOM. ANOTHER HOSOITAL WAS CALLED AHEAD AND WAS ASKED TO ORGANIZE, TRIPLE BAG, THE INSTRUMENT TRAY AND THE IMPLANTS FOR THE PROSTOP SCREW. THE GEAR WAS DROPPED OFF DOWNSTAIRS. THE LOAN SCREW WAS HANDED ONTO THE STERILE FIELD FROM ONE OF THE NURSING STAFF. WHILE THE SUR

  Patient problems: Insufficient Information

  MAUDE report 21996196 ↗