Arthrex® AR-1297LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867007239), received between Sep 12, 2024 and Sep 12, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 12, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE GUIDE PIN WITH SUTURE EYE AR-1297L IS LARGER THAN 2.4 MM. THEREFORE THE PIN COULD NOT SLIDE INTO THE AR-1204F-24I INSERT 2.4 MM. 3 PINS WITH THE SAME LOT NUMBER WERE TESTED AND ALL HAD THE SAME PROBLEM. ANOTHER PIN WITH A DIFFERENT LOT NUMBER WAS USED TO FINISH THE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199376 ↗
• MalfunctionSep 12, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE GUIDE PIN WITH SUTURE EYE AR-1297L IS LARGER THAN 2.4 MM. THEREFORE THE PIN COULD NOT SLIDE INTO THE AR-1204F-24I INSERT 2.4 MM. 3 PINS WITH THE SAME LOT NUMBER WERE TESTED AND ALL HAD THE SAME PROBLEM. ANOTHER PIN WITH A DIFFERENT LOT NUMBER WAS USED TO FINISH THE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199333 ↗
• MalfunctionSep 12, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE GUIDE PIN WITH SUTURE EYE AR-1297L IS LARGER THAN 2.4 MM. THEREFORE THE PIN COULD NOT SLIDE INTO THE AR-1204F-24I INSERT 2.4 MM. 3 PINS WITH THE SAME LOT NUMBER WERE TESTED AND ALL HAD THE SAME PROBLEM. ANOTHER PIN WITH A DIFFERENT LOT NUMBER WAS USED TO FINISH THE SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199318 ↗