Arthrex® AR-1204AS-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867004412), received between Dec 20, 2019 and May 28, 2025 — classified as 2 injuries, 5 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT SURGERY THE SIZE INDICATED ON THE PACKAGING WAS 8 BUT THE FLIP CUTTER WAS ACTUALLY A 9. PER COMPLAINT REPORTER 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. UPDATE AVOE 14-MAY-2025: IT WAS CONFIRMED THAT THE ERROR WAS DETECTED WHILE WORKING ON THE PATIENT. THERE WERE NO EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098288 ↗
• MalfunctionMay 24, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN THEY OPENED THE FLIPCUTTER AND TRIED TO DRILL, IT CLOSED. THE DEVICE DID NOT STAY OPEN FOR DRILLING. 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 19390471 ↗
• MalfunctionMay 23, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE COULD NOT BE FLIPPED AND GOT STUCK IN THE SLEEVE. NO PART OF THE DEVICE BROKE OFF. 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 19385901 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE BLADE OF THE DEVICE BROKE OFF. 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. UPDATE AVOE 14-DEC-2023 IT WAS CONFIRMED THAT THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT'S JOINT AND WAS THEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466848 ↗
• MalfunctionJul 20, 2021Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12198032 ↗
• InjuryOct 30, 2020Mechanical Problem

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE FLIPCUTTER LOCKED IN TILTED POSITION. THE SURGEON HAD TO CREATE A COMPLETE FEMORAL TUNNEL. CHANGE OF FIXATION MODE WITH FEMORAL SCREW INSTEAD OF CORTICAL BUTTON. THE SURGERY WAS COMPLETED SUCCESSFULLY, NO HARM FOR PATIENT, USER OR THIRD PARTY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10764233 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING AN ACL POST OP X-RAY THE TIP OF THE FLIP CUTTER WAS DISCOVERED INSIDE THE PATIENT. A REVISION IS SCHEDULED FOR (B)(6) 2019 TO REMOVE THE FOREIGN BODY. THE PATIENT IS A 13 YEAR OLD MALE. THE DOCTOR STATED THE OUTCOME OF THE PROCEDURE WAS SUCCESSFUL AND THE REVISION IS SOLELY TO REMOVE THE TIP FROM THE KNEE. ADDITIONAL INFORMATION OBTAINED (12/10/2019): THE SECOND PROCEDURE TO REMOVE THE TIP OF THE FLIP CUTTER WAS PERFORMED ON (B)(6) 2019 AS SCHEDULED AND IT WAS RETRIEVED SUCCESSFULLY WITH NO COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 9506122 ↗