Arthrex® AR-4520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867033559), received between Sep 6, 2017 and Oct 25, 2017 — classified as 2 injuries.

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 16, 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.

• InjuryOct 25, 2017Break; Detachment Of Device Component

  IT WAS REPORTED VIA MEDWATCH LETTER (MW5072113) THAT THE TIP OF THE ACL TR SUTURE CUTTER BROKE OFF DURING EXIT OF DEVICE FROM LEG REQUIRING SURGERY TO REMOVE THE RETAINED FOREIGN BODY. NO FURTHER INFORMATION WAS PROVIDED ON THE MEDWATCH REPORT. ADDITIONAL INFORMATION RECEIVED 10/9/2017 FROM MEDWATCH (MW5072113) REPORTER: ORIGINAL (B)(6) 2017 PROCEDURE WAS AN ARTHROSCOPY OF KNEE WITH SEMI TENDONOSIS GRACILIS, ANTERIOR COLLATERAL LIGAMENT RECONSTRUCTION WITH POSSIBLE DONOR GRAFT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE UN-RETRIEVED FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6975626 ↗
• InjurySep 6, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A FOLLOW-UP APPOINTMENT FROM ACL RECONSTRUCTION, IT WAS DISCOVERED THAT A PIECE OF THE DISTAL TIP OF THE INSTRUMENT WAS LODGED IN THE SOFT TISSUE. THIS WAS DISCOVERED DURING AN X-RAY. THE PATIENT WAS NOT COMPLAINING OF PAIN. THIS WAS A MALE PATIENT IN MID TO LATE 20S. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2017. THE BROKEN DEVICE WAS NOT DISCOVERED IN THE OR POST-OP. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2017 TO REMOVE THE TIP. FOLLOW UP INVESTIGATION: DURING REVISION SURGERY THE FRAGMENT WAS RETRIEVED WITHOUT COMPLICATION. AT THIS TIME THE FACILITY IS NOT GOING TO RELEASE THE DEVICE TO ARTHREX FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6845941 ↗