Arthrex® AR-1409LPFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867207516), received between Feb 10, 2017 and Jun 15, 2017 — classified as 2 injuries.

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.

• InjuryJun 15, 2017Break; Detachment Of Device Component; Component Missing

  IT WAS ORIGINALLY REPORTED THAT THE REAMER BROKE IN HALF WHILE DRILLING THE FEMORAL TUNNEL. NOTHING WAS LEFT IN THE PATIENT; THIS WAS CONFIRMED WITH X-RAYS AND THE ACL CASE WAS COMPLETED. PATIENT MALE, (B)(6). ADDITIONAL INFORMATION OBTAINED 6/13/2017 VIA MEDWATCH (B)(4): DATE OF PROCEDURE WAS (B)(6) 2017. AN ARTHROSCOPIC REPAIR OF THE KNEE WAS BEING PERFORMED. THE DISPOSABLE INSTRUMENT BEING USED WAS AN ARTHREX LOW PROFILE FLEXIBLE REAMER 9 MM, AR-1409LP, LOT 10034654. THE INSTRUMENT WAS INSERTED INTO THE KNEE AND USED FOR REAMING. THE INSTRUMENT WAS THEN REMOVED FROM THE KNEE AND PLACED ON THE STERILE TABLE. IT WAS THEN NOTED THAT A SMALL PIECE OF THE FLEXIBLE METALLIC PORTION HAD BROKEN OFF AND WAS MISSING. THIS PIECE HAD NOT BEEN MISSING BEFORE THE INSTRUMENT WAS USED. THE MISSING AREA WAS APPROXIMATELY 5 MM X 5 MM. DOCTOR WAS NOTIFIED AND THE SURGICAL AREA WAS INSPECTED BUT THE MISSING PIECE COULD NOT BE LOCATED. THE SURGERY PROCEEDED WITHOUT COMPLICATIONS AND AN X-RAY OF THE KNEE WAS OBTAINED BEFORE THE SURGICAL SITE WAS CLOSED. THE X-RAY WAS FOUND TO BE NEGATIVE BY THE DOCTOR AND THE X-RAY WAS ALSO SENT BY THE X-RAY TECH TO BE READ BY A RADIOLOGIST. THE SURGICAL SITE WAS CLO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642771 ↗
• InjuryFeb 10, 2017Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BTB AUTOGRAFT ACL REPAIR PROCEDURE ON (B)(6) 2017 AND DURING THE PROCEDURE, THE 9MM LOW PROFILE REAMER BROKE AS THE SURGEON WAS DRILLING THE FEMORAL TUNNEL. THE REAMER BROKE ABOUT 20MM DEEP AND WAS REMOVED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. ON (B)(6) 2017, THE SURGEON REACHED OUT TO THE REP TO REPORT THAT WHILE OBSERVING THE PATIENT'S POST-OP X-RAY, IT LOOKED AS IF THERE WAS STILL METAL FROM THE REAMER IN THE PATIENT. THE SURGEON STATED THAT HE MAY HAVE TO SCHEDULE A REVISION SURGERY TO RE-SCOPE THE KNEE. SURGEON PLANS TO OBSERVE PATIENT OVER NEXT SEVERAL WEEKS TO SEE IF THE PIECE DRIFTS. IF THE PIECE MOVED THEN A REVISION SURGERY WILL BE SCHEDULED. IF THE PIECES STAYS PUT THE SURGEON DOES NOT PLAN TO GO IN TO RETRIEVE THE FRAGMENT. PATIENT IS A (B)(6) Y/O MALE WEIGHING (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 6321836 ↗