Arthrex® AR-1249-1SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867271593), received between May 25, 2023 and May 18, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIP OF THE NITINOL PIN BROKE INSIDE THE PATIENT WITHOUT THE SURGEON APPLYING ANY PARTICULAR FORCE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USING THE OTHER END OF THE PIN. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200181 ↗
• InjuryMar 18, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHILE THE SURGEON WAS REMOVED THE GUIDE THE TIP BROKE OFF. THE SURGEON TOOK A X-RAY PICTURE AND IDENTIFIED THAT THE TIP REMAINED INSIDE THE PATIENT. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN TIP THROUGH ARTHROSCOPY FOR ONE HOUR BUT WAS UNSUCCESSFUL AND DECIDED THEN TO OPEN THE WOUND TO REMOVE THE BROKEN TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 24631672 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE GUIDEWIRE BROKE OFF INSIDE PATIENT AFTER INSERTING THE FAST THREAD SCREW. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569232 ↗
• InjurySep 7, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE WIRE BROKE AT THE LASER MARKING. A 2CM PIECE OF WIRE REMAINED IN THE PATIENTS JOINT REQUIRING ADDITIONAL SURGERY ON (B)(6) 2023. AFTER THE SECOND SURGERY ALL BROKEN-OFF PIECES COULD BE RETRIEVED. 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.

  Patient problems: Foreign Body In Patient

  MAUDE report 17699549 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY A FRAGMENT OF THE GUIDE PIN BROKE. IT WAS POST OPERATIVELY IDENTIFIED VIA XR CHECK THAT THE FRAGMENT REMAINED IN THE PATIENT. A SECOND SURGERY IS REQUIRED TO REMOVE THE FRAGMENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17007349 ↗