Arthrex® AR-1409LP-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867016774), received between May 10, 2018 and May 8, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1204AF-95, FLIPCUTTER® II, 9.5 MM BENT AFTER IT FLIPPED AND WHILE DRILLING FEMUR TUNNEL AND AN AR-1409LP-50, LOW PROFILE REAMER, 9.5 MM, BROKE UPON DRILLING THE TIBIA TUNNEL. THIS WAS DETECTED DURING USE IN AN ACL RECONSTRUCTION SINGLE BUNDLE PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW FLIPCUTTER AND THE REAMERS FROM THE SET ITSELF.

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

  MAUDE report 21987101 ↗
• MalfunctionMay 6, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1409LP-50, LOW PROFILE REAMER, 9.5 MM, THE REAMER TIP BROKE UPON DRILLING THE TIBIA. THIS WAS DETECTED DURING USE IN A LEFT KNEE ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE REAMER FROM THE SET.

  Patient problems: Insufficient Information

  MAUDE report 21972759 ↗
• InjuryMar 7, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 03/10/2025: THE PART AND LOT NUMBER OF THE REAMER WAS AR-1409LP-50 LOW PROFILE REAMER, 9.5 MM FROM LOT 4248152395. THE SECOND SURGERY WAS ON 01/16/2025. THERE WERE NO ARTHREX PARTS EXPLANTED OR IMPLANTED. THE PATIENT'S STATUS IS NORMAL POST-OP ACL. AN X-RAY WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21549489 ↗
• MalfunctionJun 13, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1409LP-50 LOW PROFILE REAMER TIP BROKE IN HALF INSIDE OF THE PATIENT'S BONE, WHEN THE SURGEON WAS ATTEMPTING TO REAM THE FEMORAL TUNNEL. THIS OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14676691 ↗
• InjuryMay 10, 2018Break; Detachment Of Device Component

  IT WAS REPORTED BY THE REPRESENTATIVE THAT DURING AN ACL PROCEDURE, THE GUIDE WIRE WAS INTRODUCED, WENT STRAIGHT IN, THEN THE REAMER WAS PUT OVER TOP OF THE WIRE. WHEN IT CAME IN CONTACT WITH THE BONE THE ENTIRE HEAD OF THE REAMER BROKE OFF. IT NEVER MADE IT INTO THE JOINT. IT BROKE WHEN IT MADE CONTACT WITH THE CORTEX. OPENED A DIFFERENT MANUFACTURER'S REAMER AND COMPLETED THE PROCEDURE WITHOUT INCIDENT. PATIENT: (B)(6) FEMALE. THE BROKEN PIECE WAS NEVER FOUND BUT IT WAS CONFIRMED BY THE SURGEON THAT IT DID NOT REMAIN IN THE PATIENT. SURGEON DID NOT ORDER X-RAYS. FOLLOW-UP INVESTIGATION: THE REAMER HEAD BROKE INTO TWO PIECES. ONE PIECE WAS RECOVERED AND HAS BEEN RETURNED FOR EVALUATION WITH THE SHAFT. THE SALES REP STATES THAT SURGEON FELT AND ALSO VISUALIZED THE INCISION A SECOND TIME BEFORE CLOSING. THE DEVICE PIECE WAS NOT LOCATED.

  Patient problems: No Code Available

  MAUDE report 7502472 ↗