Arthrex® AR-1410LPFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867207523), received between Jan 29, 2018 and May 7, 2019 — 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.

• InjuryMay 7, 2019Break

  IT WAS REPORTED DURING AN ACL RECONSTRUCTION THE TIP OF THE AR-1400F-100 FLEXIBLE REAMER BROKE WHEN THE DOCTOR STARTED DRILLING. WHEN THE REAMER WAS PULLED OUT IT WAS NOTICED THE TIP WAS MISSING. THE DOCTOR FELT ALL WAS RETRIEVED. THE REP NOTED THAT THE LOCATION THE DOCTOR WAS DRILLING WAS VERY HARD BONE. IT WAS REPLACED WITH AN AR-1410LPF LOW PROFILE FLEXIBLE REAMER AND THE SAME EVENT OCCURRED. ONCE AGAIN THE DOCTOR RETRIEVED THE BROKEN FRAGMENTS. THE REAMER WAS REPLACED A THIRD TIME WITH ANOTHER AR-1410LPF AND THE TIP OF THE THIRD BROKE AS WELL. AGAIN THE DOCTOR REMOVED THE FRAGMENTS. AT THIS POINT THE DRILLING WAS COMPLETED. THEN THE REST OF THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. A FEW WEEKS LATER DURING A FOLLOW UP EXAM AND X-RAY IT WAS DISCOVERED THERE IS STILL A FRAGMENT LEFT IN THE TISSUE. A SECOND SCOPE PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8587992 ↗
• InjuryJan 29, 2018Break; Detachment Of Device Component; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, APPROXIMATELY 10 MM INTO REAMING THE FEMORAL TUNNEL WHILE USING THE LOW PROFILE FLEXIBLE REAMER (LOT: 10041788), THE PIECES BETWEEN 50-35 MM BROKE-OFF INTO THE JOINT SPACE. AT THE 35 MM MARK TO THE TIP OF THE REAMER WAS LEFT INTACT, HOWEVER, WAS DETACHED FROM THE REAMER AS A SEPARATE PIECE. SIX BRACKETS BECAME LOOSE FRAGMENTS AND WERE ABLE TO BE RETRIEVED THROUGH A SECOND INCISION. A 7TH FRAGMENT WAS SEEN ON A POST-OP X-RAY IN THE TIBIAL TUNNEL IN BETWEEN BONE BLOCK AND BONE TUNNEL. THE SURGEON STATED THAT THE PIECE WAS "INSIGNIFICANT AND INCONSEQUENTIAL". DURING THE SAME CASE, WHILE THE SURGEON WAS TAPPING THE FEMORAL BONE TUNNEL AFTER THE INSERTION OF THE BTB ALLOGRAFT, THE 7 MM FLEXIBLE SCREW TAP (LOT: 41641548) SNAPPED AT THE JUNCTION OF THE SOLID STEM AND THE FLEXIBLE BRACKETS WHILE THE TAP WAS BEING ADVANCED, NOT RETRACTED. NO FRAGMENTS BECAME LOOSE IN THE JOINT SPACE. A VICE LIKE DEVICE WAS USED TO CLAMP DOWN ON THE BRACKETS AND BACK OUT THE TAP. FOLLOW-UP INVESTIGATION: THE INCISION THAT WAS MADE ON THE ANTERIOR PORTION OF THE KNEE SO THAT THE SURGEON COULD HARVEST THE GRAFT, HAD TO BE REOPENED TO RETRIEVE A PORTION OF THE BRACK

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7224271 ↗