Arthrex® AR-1399Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867015890), received between Nov 30, 2017 and Dec 2, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Break

  ON 11/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1399 CANNULATED SCREWDRIVER IS BROKEN. THIS OCCURRED DURING A CASE WHEN THE DEVICE BROKE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904176 ↗
• InjuryNov 30, 2017Break; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2017, THE SURGEON PERFORMED A PROCEDURE TO REMOVE A PREVIOUSLY IMPLANTED SCREW. HE INSERTED THE K-WIRE THROUGH THE SCREW AND FITTED THE PINLOCK SCREWDRIVER TO THE SCREW. WHEN HE ATTEMPTED TO REMOVE THE SCREW, THE TIP OF THE DRIVER BECAME DAMAGED. THE TIP OF THE DRIVER REMAINED ON THE SCREW AND THE SURGEON WAS UNABLE TO REMOVE THE SCREW. AT THIS TIME, THE PROCEDURE WAS ENDED. FOLLOW-UP INVESTIGATION: THIS WAS THE REMOVAL PROCEDURE OF AN ARTHREX SCREW USED IN THE ACL RECONSTRUCTION PROCEDURE THAT WAS PERFORMED 8 YEARS AGO.

  Patient problems: Foreign Body In Patient

  MAUDE report 7070100 ↗