Arthrex® AR-1204AF-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867004153), received between Jun 14, 2019 and May 20, 2024 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 03/04/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-1204AF-120 FLIPCUTTER PACKAGING WAS DAMAGED, AND DECLARED UNSUITABLE FOR THEIR SHELF. THIS WAS DISCOVERED UPON RECEIVING, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351048 ↗
• MalfunctionJul 6, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE FLIPCUTTER BROKE OFF AS SOON AS DRILLING BEGAN ON THE CORTICAL SURFACE OF THE FEMUR. THE TIP WAS RETRIEVED AND THE CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124302 ↗
• InjuryJan 26, 2021Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE SURGEON WAS PERFORMING A RIGHT KNEE POSTERIOR CRUCIATE LIGAMENT AND POSTERIOR LATERAL CORNER RECONSTRUCTION. INTRA-OPERATIVELY THE TIBIAL AND FEMORAL BONE SOCKETS WERE REAMED WITH AN AR-1204AF-120, 12MM FLIPCUTTER II (LOT 816684176). TO LENGTHS OF 40MM AND 35 MM RESPECTIVELY. THE BLADE WAS CHANGED FROM CUTTING ORIENTATION BACK TO DRILLING ORIENTATION INSIDE THE FEMORAL SOCKET WITHOUT VISUAL OBSERVATION. THE GRAFT WAS PASSED, TENSIONED AND FIXATED WITH BUTTON. THIS WAS ALL COMPLETED WITHOUT ANY TEAM MEMBERS NOTICING ANY ISSUE. SURGEON TOOK A POST OPERATIVE RADIOGRAPHIC IMAGE AFTER THE STERILE DRESSINGS WERE PLACED AND DISCOVERED A RETAINED BROKEN BLADE FROM THE FLIPCUTTER II. THE PATIENT HAD UNDERGONE A LENGTHY SURGERY WITH MAXIMUM TOURNIQUET TIME AND SURGEON MADE THE DECISION TO BRING PATIENT BACK AT A LATER DATE TO ARTHROSCOPICALLY REMOVE THE RETAINED FRAGMENT. ADDITIONAL INFORMATION 1/6/2020: PROCEDURE SCHEDULED FOR (B)(6) 2020 TO REMOVE THE RETAINED FRAGMENT. ADDITIONAL INFORMATION 1/11/2021: IT HAS BEEN CONFIRMED THAT THE FLIPCUTTER II FRAGMENT WAS ARTHROSCOPICALLY REMOVED FROM THE PATIENT ON (B)(6) 2021. THE FLIPCUTTER II AND FRAGMENT AR

  Patient problems: Foreign Body In Patient

  MAUDE report 11228593 ↗
• InjuryJun 14, 2019Break; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT DURING A REVISION ACL RECONSTRUCTION WITH ACHILLES-CALCANEUS ALLOGRAFT THE ARTHREX FLIPCUTTER II BROKE AT THE BEGINNING OF DRILLING THE TIBIAL SOCKET. SURGEONS WERE ABLE TO REMOVE THE BROKEN BLADE WHICH WAS NEAR THE TIBIAL TUNNEL. THIS WAS REPORTED TO BE A COMPLEX ACL REVISION CASE WITH PROMINENT DEFICIENCY OF THE BONE IN THE TIBIA. FOR THIS REASON THE SURGEON CHOSE TO USE THE LARGEST FLIPCUTTER II (12.0 MM) IN ORDER TO ACCOMMODATE THE LARGE BONE BLOCK. AFTER THE FLIPCUTTER BROKE, TO COMPLETE THIS PORTION OF THE PROCEDURE, THE SURGEON CHOSE TO USE ANOTHER MANUFACTURER¿S DEVICE. INSTEAD OF USING AN ALL-INSIDE TECHNIQUE, TO CREATE TWO SOCKETS IN THE TIBIA, THE SURGEON USED A CONVENTIONAL DRILL AND CREATED A FULL TIBIAL TUNNEL. IT WAS NOTED THAT THE SURGEON DID USE A FLIPCUTTER (10 MM) ON THE FEMUR WITH NO ISSUES. UPDATE 05-JUN-2019: THIS WAS CONFIRMED TO HAVE BEEN A REVISION CASE OF A PREVIOUS ACL RECONSTRUCTION WHICH WAS PERFORMED YEARS PRIOR. THE REPORTER HAS NO INFORMATION REGARDING THE PREVIOUS ACL RECONSTRUCTION AND THEREFORE IT CANNOT BE CONFIRMED IF THE ORIGINAL RECONSTRUCTION INVOLVED ANY ARTHREX PRODUCTS.

  Patient problems: No Information

  MAUDE report 8699708 ↗