Arthrex® AR-1204AF-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867004122), received between Jun 26, 2019 and Sep 19, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Break; Break

  ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1204AF-105, FLIPCUTTER® II, 10.5 MM, THE TIP BROKE WHILE DRILLING. THIS WAS DETECTED DURING A PCL RECONSTRUCTION WITH ALLOGRAFT AND INTERNAL BRACE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1204AF-105. THE TIP WAS BREAK OFF INSIDE THE PATIENT AND THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23094975 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE FLIPCUTTER 10.5 HAS BEEN USED AND INSTANTLY BROKE WHEN THEY HAVE STARTED DRILLING. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412036 ↗
• MalfunctionFeb 10, 2025Break; Break

  ON 01/16/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1204AF-105 FLIPCUTTERS TIP BROKE. THIS OCCURRED DURING AN ACL RECONSTRUCTION WHERE THE RETROGRADE DRILL ENTERED THE FEMORAL CONDYLE 5 MM AND BROKE AT ITS TIP. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21343635 ↗
• MalfunctionSep 19, 2022Break; Break; Material Disintegration

  THE SURGEON HAD THREE FLIPCUTTER II DISINTEGRATE IN THE KNEE AS DRILLING FEMORAL TUNNEL. THE FIRST TIME THEY STARTED DRILLING WITH BLADE ON BONE AND THE REP INSTRUCTED THEM TO START THE DRILLING AT FULL SPEED BEFORE PULLING BACK ONTO THE BONE. BUT THE SAME THING HAPPENED ON THE SECOND AND THE THIRD TIME. THE PATIENT WAS A 17 YEAR OLD MALE. ON ALL THREE OCCASIONS, THE METAL PIECES OF THE DEVICE BROKE OFF AND NEEDED TO BE RETRIEVED BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15445916 ↗
• MalfunctionSep 19, 2022Break; Break; Material Disintegration

  THE SURGEON HAD THREE FLIPCUTTER II DISINTEGRATE IN THE KNEE AS DRILLING FEMORAL TUNNEL. THE FIRST TIME THEY STARTED DRILLING WITH BLADE ON BONE AND THE REP INSTRUCTED THEM TO START THE DRILLING AT FULL SPEED BEFORE PULLING BACK ONTO THE BONE. BUT THE SAME THING HAPPENED ON THE SECOND AND THE THIRD TIME. THE PATIENT WAS A 17YEAR OLD MALE. ON ALL THREE OCCASIONS, THE METAL PIECES OF THE DEVICE BROKE OFF AND NEEDED TO BE RETRIEVED BY THE SURGEON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 15445904 ↗
• MalfunctionJun 6, 2022Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RESTORATION THE DEVICES AR-1204AF-105 (LOT: 1335117583) BROKE DURING DRILLING INWARD INTO THE JOINT. THE BREAKAGE POINT WAS OUTSIDE OF THE PATIENT. 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 14603537 ↗
• MalfunctionDec 27, 2021Break; Output Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY THE MECHANISM OF THE DEVICE DID NOT WORK. WHEN THE SURGEON USED THE FLIPCUTTER IN THE PATIENT'S KNEE, THE SPINNER AT THE END OF THE FLIPCUTTER OPENED BUT COULD NOT BE CLOSED TO PULL THE METAL END OUT. WHAT TURNS AT THE END OF THE FLIPCUTTER DID NOT TURN WELL AND ALMOST GOT STUCK INSIDE THE KNEE. PART OF THE DIVIDE BROKE OFF INSIDE THE PATIENT AND THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. 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 17-DEC-2021: IT WAS CONFIRMED THAT A PART OF THE MECHANISM BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087950 ↗
• MalfunctionNov 2, 2021Material Separation

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1204AF-105 FLIPCUTTER II BROKE. THIS OCCURRED DURING A REVISION ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2021. SURGEON WAS DRILLING THE FEMORAL TUNNEL, MAINLY THROUGH SOFT TISSUE AND SOME BONE, WHEN THE TIP OF THE FLIPCUTTER BROKE INSIDE PATIENT. THE TIP WAS REMOVED USING A GRASPER AND A NEW FLIPCUTTER DEVICE WAS OPENED WITH NO MORE ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12737840 ↗
• MalfunctionApr 1, 2021Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AT THE MOMENT THAT THE AR-1204AF-105, MAKES CONTACT WITH THE TIBIAL BONE, THE TIP OF THE AR-1204AF-105, BROKE WITHIN THE JOINT SPACE. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1204AF-105 WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11602653 ↗
• InjuryJun 26, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ACL PROCEDURE ON (B)(6) 2019 WHERE A FLIPCUTTER, AR-1204AF-105, WAS USED. DURING RETRO-DRILLING OF THE FEMORAL TUNNEL, THE CUTTER BROKE OFF. THE CUTTER WAS UNABLE TO BE RETRIEVED AND THE PATIENT WAS SCHEDULED FOR A SECOND SURGERY TO HAVE THE CUTTER REMOVED. THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2019 AND HAD THE CUTTER REMOVED WITH NO INCIDENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE FACILITY DISCARDED BOTH PARTS OF THE FLIPCUTTER AFTER THE CASE AND NO X-RAYS WERE TAKEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8734620 ↗