Arthrex® AR-1218-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867087774), received between Apr 21, 2017 and Aug 15, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionAug 15, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1218-40 DRILL BIT BROKE WHEN IT WAS BEING USED AFTER STERILIZATION. THIS WAS DISCOVERED DURING A CASE WITHIN THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 15224068 ↗
• InjuryJul 17, 2018Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 4MM CANNULATED DRILL BROKE AND THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED FROM PATIENT BODY. NO FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED: THIS WAS ACL RECONSTRUCTION PROCEDURE. WHEN THE SURGEON INSERTED THE DRILL THROUGH THE GUIDE, THE DRILL BROKE. HE TRIED TO RETRIEVE FRAGMENT, BUT WAS UNSUCCESSFUL AND THE FRAGMENT REMAINED IN THE PATIENT. THE PATIENT IS MALE, (B)(6).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7693342 ↗
• InjuryApr 21, 2017Break

  IT WAS REPORTED THAT DURING AN ACL REVISION PROCEDURE TO REMOVE ANOTHER MANUFACTURER'S DEVICE(S), THE SURGEON REMOVED THIS PRIMARY IMPLANT AND RESIDUAL SUBSTANCE FROM THE PATIENT'S JOINT AND ATTEMPTED TO DRILL THE PRIMARY HOLE AGAIN USING THE 4 MM CANNULATED DRILL (LOT: 10062206). WHILE DRILLING, THE SURGEON FELT RESISTANCE AND IT WAS THEN THAT HE NOTICED THAT THE CANNULATED DRILL HAD BROKEN. THE SURGEON TRIED TO RETRIEVE EVERY FRAGMENT OF THE DRILL HOWEVER, WAS UNSUCCESSFUL AND SOME FRAGMENTS WERE LEFT IN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6511018 ↗