Arthrex® AR-1409LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867016767), received between Nov 21, 2017 and Feb 1, 2024 — classified as 2 injuries, 3 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Break; Break

  ON 01/11/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1409LP LOW PROFILE REAMER TIP BROKE OFF. THIS OCCURRED DURING A RIGHT KNEE ARTHROSCOPY, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PATELLA TENDON AUTOGRAFT AND MEDIAL MENISCAL REPAIR WHERE ALL BROKEN FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 18624784 ↗
• MalfunctionJan 11, 2024

  SURGICAL ATTENDING INFORMED CIRCULATING RN THAT THE ARTHREX REAMER DRILL BIT TIP BROKE OFF - PIECES WERE COLLECTED AND NO HARM TO THE PATIENT. THE BROKEN ITEM WAS AN ARTHREX LOW PROFILE REAMER 9MM. ITEM # AR-1409LP, LOT # 15125284, AND EXPIRATION DATE OF 07/31/2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491051 ↗
• MalfunctionApr 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1409LP REAMER, LOW PROFILE BROKE WHEN REAMING THE TIBIA. HARD BONE CAUSED THE WINGS OF THE REAMER TO BREAK OFF WHEN REAMER IMPACTED TIBIAL BONE WHEN REAMING OVER GUIDE WIRE. WINGS COULD NOT BE LOCATED. POST OP X-RAYS SHOWED METAL PIECES IN PATIENTS LEG MEDIAL TO TIBIAL TUNNEL. ON 04/06/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022. ANOTHER REAMER WAS USED TO COMPLETE THE CASE. THE PATIENT IS FINE TO DATE AND HAS NO EFFECT RECORDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14135718 ↗
• InjuryNov 21, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT A BONE TENDON BONE SURGERY WAS PERFORMED. DURING THE FEMORAL DRILLING OVER THE DRILL PIN, THE TIP OF THE LOW PROFILE DRILL HAS BROKEN OFF. THE DRILL PIN WAS THEN SLIGHTLY BENT. THE SURGEON WANTED TO RETRIEVE THE BROKEN FRAGMENT OF THE DRILL FROM THE KNEE, BUT COULD NOT FIND IT. THE PATIENT WAS X-RAYED DURING THE SURGERY TO FIND THE BROKEN FRAGMENT, BUT THE SURGEON COULD NOT LOCATE IT ON THE IMAGE CONVERTER. THE BROKEN PART REMAINS IN THE PATIENT'S KNEE. ACCORDING TO THE SURGEON, HE DOES NOT WANT TO PERFORM A SECOND SURGERY. OVERALL, IT WAS A VERY DIFFICULT SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ARTHREX DEVICE AR-1409.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9353297 ↗
• InjuryNov 21, 2017Material Fragmentation

  IT WAS REPORTED THAT AS THE SURGEON WAS PERFORMING AN ARTHROSCOPIC LEFT KNEE ACL RECONSTRUCTION PROCEDURE, THE HEAD OF THE REAMER BROKE AS IT WAS BEING STARTED. THE HEAD OF THE REAMER WAS IN CONTACT WITH THE PATIENT'S BONE AND BROKE INTO THREE PIECES - SHAFT AND TWO BLADES. ONE OF THE BLADES WAS EMBEDDED INTO THE BONE AND THE OTHER WAS LOST FROM VIEW. THE SALES REP SUGGESTED TO CHECK THE POSTERIOR COMPARTMENT AND A BASIC EXAMINATION WAS CARRIED OUT. THE SURGEON WAS UNCONCERNED, HOWEVER, REQUESTED AN X-RAY BE TAKEN WHILST IN RECOVERY. FOLLOW-UP INVESTIGATION: DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS KEPT BY THE HOSPITAL IN A SHARPS CONTAINER AND CANNOT BE RETRIEVED. THE THIRD PIECE OF THE DEVICE WAS LEFT IN THE POSTERIOR COMPARTMENT OF THE PATIENT'S JOINT. AN IMAGE INTENSIFIER WAS USED TO LOCATE THE FRAGMENTS AND THEREFORE A PICTURE IS UNABLE TO BE PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7048070 ↗