Arthrex® AR-1941PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867351417), received between Jul 30, 2025 and Feb 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Material Twisted/Bent

  ON 05-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-1941PK PERC KIT FOR 3.9MM KNOTLESS CORKSCREW HAD A BENT DILATOR OUT OF THE PACKAGE AND WOULD NOT SLIDE WITH THE GUIDE DUE TO THE DIFFICULTY OF SLIDING THE GUIDE OVER THE TOP OF THE DILATOR THE SURGEON NEEDED TO USE A SMALLER SWITCHING STICK TO MOVE FORWARD WITH THE CASE. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428701 ↗
• MalfunctionJul 30, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1941PK, TRANSTENDON PERCUTANEOUS INSERTION KIT COMPATIBLE WITH 3.9MM KNOTLESS CORKSCREW®/ KNOTLESS FIBERTAK® ANCHORS, THE CANNULATED SWITCHING STICK WAS BLOCKED AND WAS UNABLE TO BE PASSED OVER THE WIRE. THIS WAS DETECTED DURING USE IN A REMPLISSAGE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A SECOND KIT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 22663080 ↗