Arthrex® AR-8740-48HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867127906), received between Jun 7, 2021 and Apr 15, 2024 — classified as 1 injury, 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. 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.

• InjuryApr 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 3/20/2024, AN INQUIRY WAS SUBMITTED BY A NURSE CASE MANAGER VIA PHONE FOR A PATCH TEST KIT ON BEHALF OF A PATIENT AND SURGEON. THE PATIENT IS EXPERIENCING SEVERE ITCHING ON BOTH ANKLES AND FEMUR WHERE THE AR-8740-40H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 40 MM, AR-8740-48H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 48 MM, AND AR-8740-50H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 50 MM WAS IMPLANTED. THEY WOULD LIKE TO KNOW IF THESE SCREWS ARE THE CAUSE OF THE SENSITIVITY THE PATIENT IS EXPERIENCING. IF PROVEN, THERE WILL BE AN ADDITIONAL SURGERY TO REMOVE THE SCREWS. ADDITIONAL INFORMATION WAS RECEIVED ON 3/22/2024: MATERIAL COMPOSITION WAS REQUESTED BY THE NURSE CASE MANAGER ON AR-8740-40H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 40 MM, AR-8740-48H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 48 MM, AND AR-8740-50H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 50 MM THAT WAS IMPLANTED IN THE PATIENT DURING A ORIF OF LEFT AND RIGHT TALUS AS WELL AS ARTHROSCOPY WITH FOREIGN BODY REMOVAL OF LEFT AND RIGHT ANKLE ON (B)(6) 2021. SCREWS WERE USED BILATERALLY. THE SYMPTOMS OF SEVERE ITCHING AND SKIN IRRITATION HAVE BEEN OCCURRING SINCE SHORTLY AFTER THIS TIME AND THE PATIENT HAS BEEN TRE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19107070 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, WHEN THE SURGEON WAS ENTERING THE SCREW, IT BREAKS WITHOUT BEING FORCED. THE SURGEON WAS ABLE TO REMOVE THE DEVICE BY USING AN INSTRUMENTS FROM ANOTHER MANUFACTURER. THE CASE WAS COMPLETED BY USING A NEW DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 11946541 ↗