Arthrex® AR-1298FLXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867274143), received between Dec 5, 2018 and Jun 20, 2024 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE OFF AND HAD TO BE REMOVED FROM THE JOINT. 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 19573567 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1298FLX FLEXIBLE TIGHTROPE® DRILL PIN HAD AN ISSUE. THE PIN TIP BROKE OFF WHEN THE DOCTOR BEGAN TO USE IT. PATIENT WAS NOT AFFECTED OR HARMED AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON (B)(6) 2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022. THE PIN TIP BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THE PATIENT HAD NORMAL BONE QUALITY, A NEW PIN WAS PROVIDED AND THE CASE WAS COMPLETED WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14195783 ↗
• InjuryDec 5, 2018Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A LEFT ACL PROCEDURE, THE SPADE TIP OF THE FLEXIBLE TIGHTROPE® DRILL PIN, AR-1298FLX, BROKE OFF INSIDE OF THE PATIENT'S FEMUR AS THE SURGEON WAS ATTEMPTING TO REVERSE THE PIN OUT OF THE BONE TO READJUST POSITION. THE SURGEON DECIDED TO LEAVE THE BROKEN FRAGMENT IN THE FEMUR AND COMPLETED THE TUNNEL WITH A FLIPCUTTER INSTEAD. THE CASE WAS THEN COMPLETED WITH NO FURTHER INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8132825 ↗