Arthrex® AR-1941PSVRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867344921), received between Jan 19, 2021 and Apr 26, 2024 — classified as 1 injury, 2 malfunctions.

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 16, 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.

• MalfunctionApr 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 09/09/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1941PSV 3.9 MM KNOTLESS CORKSCREW®FAILED. THE TEAM USED A REUSABLE GUIDE AND PUNCH AND FOLLOWED PROPER TECHNIQUE FOR INSERTION. AFTER THE SURGEON PASSED THE REPAIR STITCH FROM HER FIRST ANCHOR, THEY HEARD A SOUND WHILE SHE WAS TENSIONING AND REALIZED THE ANCHOR PULLED OUT. SHE THEN REMOVED THE PROTRUDING ANCHOR, CUT OUT THE SUTURE, AND LEFT THE SECOND ONE SINCE THE CONSTRUCT COULD NO LONGER BE COMPLETED. THE PATIENT WAS 28 YEARS OLD AND APPEARED TO HAVE GOOD BONE. THE DOCTOR DECIDED TO NOT MOVE FORWARD WITH THE REMPLISSAGE AFTER THE ANCHOR FAILED. ADDITIONAL INFORMATION PROVIDED 09/10/2021 THE DEVICE WILL NOT BE RETURNING. THE INSTRUMENTS USED TO PREPARE THE BONE WERE AR-1941P (PUNCH), AND AR-1941CT (GUIDE)

  Patient problems: Insufficient Information

  MAUDE report 19191539 ↗
• MalfunctionFeb 22, 2024Break; Break

  ON 2/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1941PSV PEEK KNOTLESS CORKSCREW ANCHOR BROKE WHEN SHUTTLING THE REPAIR STITCH THROUGH THE ANCHOR BODY. THE SURGEON WAS UNABLE TO TENSION DOWN FULLY. THE ANCHOR WAS REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1941PSV PEEK KNOTLESS CORKSCREW ANCHOR. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18761655 ↗
• InjuryJan 19, 2021Break; Crack

  IT WAS REPORTED THAT A SURGEON WAS DOING A REMPLISSAGE USING 3.9 KNOTLESS CORKSCREWS (AR-1941PSV, LOT 10747047). SURGEON USED A DISPOSABLE KIT (AR-1941DS, LOT 11238107), WITH GUIDE AND PUNCH AND FOLLOWED PROPER TECHNIQUE FOR INSERTION. AS SURGEON BEGAN TWISTING THE ANCHOR IN, SHE HEARD A SOUND AND THEN SAW THE ANCHOR WAS CRACKED. THE ANCHOR WAS ALMOST FULLY INSERTED BUT SITTING A BIT PROUD. SURGEON TRIED TO REMOVE THE CRACKED ANCHOR BODY BUT HAD A HARD TIME SO SHE ENDED UP REMOVING AND CUTTING OUT THE SUTURES AND THE ANCHOR BODY REMAINED IN THE PATIENT BUT DID NOT CAUSE HARM. THE CASE WAS COMPLETED BY USING 2 NEW ANCHORS WITH THE SAME LOT NUMBER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11192523 ↗