Arthrex® AR-7501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867288812), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 25, 2023Break; Break

  ON 9/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06045007 THAT AN AR-13999HDN HD SCORPION NEEDLE WITH MEGALOADER, VE5, HAD AN ISSUE. THE SURGEON WAS COMPLETING AN AFLEX 301 PATCH OVER A ROTATOR CUFF, SIDE-SIDE REPAIR. THE SURGEON PLACED AND TIED 3 SUTURETAPES, STARTING ANTEROLATERAL AND MOVING POSTERIORLY. ON ATTEMPTING TO PLACE A FINAL SUTURE TAPE ON THE POSTEROLATERAL CORNER OF THE PATCH/CUFF TISSUE, THE DISTAL 8-9MM OF THE HD SCORPION NEEDLE BROKE OFF, CUTTING THE SUTURE. ON PULLING THE SCORPION OUT OF THE JOINT, THE BROKEN NEEDLE TIP FLEW OUT AND LANDED ON THE BACK SCRUB TABLE. THE SURGEON STATED AFTER THE CASE, ¿I FELT THE NEEDLE BEND AS I FIRED IT THROUGH THE PATCH.¿ THE CASE WAS COMPLETED USING ANOTHER AR-13999HDN HD SCORPION NEEDLE AND SEVERAL PACKS OF AR-7501 WITH A DELAY OF 4-5 MINUTES WHILE RETRIEVING AND OPENING A NEW SCORPION HD NEEDLE. THERE WAS NO ADDITIONAL ANESTHESIA NEEDED. THIS WAS DISCOVERED DURING ROTATOR CUFF REPAIR WITH A PATCH AUGMENTATION PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18002086 ↗