Arthrex® AR-1250LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867006270), received between Jun 18, 2024 and Jul 25, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Unintended Movement; Unintended Movement

  ON 07/03/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-1250LS DRILL TIP GUIDE PIN SLEEVE ROTATED ALONG WITH THE DRILL. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610931 ↗
• MalfunctionJun 18, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY IT WAS NOTICED THAT WITH THE AR-1409 THE PIN GOT STUCK IN THE CANNULATED DRILL BIT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19563810 ↗