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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867004290), received between Oct 31, 2017 and Sep 16, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Break; Break

  ON 08/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1204AS-105 FLIPCUTTER WAS BEING USED IN AN ACL RECONSTRUCTION AND WHEN THEY WERE PULLING BACK IN THE SOCKET ON FULL SPEED, THE FLIPCUTTER BROKE IN THE SOCKET ON THE FEMUR. 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 23063402 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ACL SURGERY THE DISTAL TIP OF THE DEVICE FELL INSIDE THE JOINT WHEN THE SURGEON TRIED TO CLOSE THE DRILLING METAL PART BEFORE PULLING IT OUT. ALL PARTS WERE 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 21891990 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE FLIPCUTTER BROKE. ALL FRAGMENTS WERE 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 21026573 ↗
• MalfunctionAug 28, 2024Break; Break

  08/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1204AS-105 FLIPCUTTER BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085986 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 10/1/2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA (B)(4) THAT (AR-1204AS-105 FLIPCUTTER II TIP BROKE OFF AND ANTHER FLIPCUTTER II COULD NOT FINISH CORING THE TUNNEL. THIS WAS FOUND DURING AN ACL RECONSTRUCTION ON (B)(6) 2021, WHEN SURGEON DRILLED FEMORAL TUNNEL, TIP OF FLIPCUTTER BROKE OFF, ONCE THE METAL TIP WAS RETRIEVED FROM PATIENT A NEW FLIPCUTTER II WAS OPENED BUT IT WAS NOT ABLE TO FINISH CORING THE TUNNEL. SURGEON HAD TO OPEN A THIRD FLIPCUTTER II TO COMPLETE CASE SUCCESSFULLY; PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492415 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 10/1/2021, IT WAS REPORTED BY SALES REPRESENTATIVE VIA (B)(4) THAT (AR-1204AS-105 FLIPCUTTER II TIP BROKE OFF AND ANTHER FLIPCUTTER II COULD NOT FINISH CORING THE TUNNEL. THIS WAS FOUND DURING AN ACL RECONSTRUCTION ON (B)(6) 2021, WHEN SURGEON DRILLED FEMORAL TUNNEL, TIP OF FLIPCUTTER BROKE OFF, ONCE THE METAL TIP WAS RETRIEVED FROM PATIENT A NEW FLIPCUTTER II WAS OPENED BUT IT WAS NOT ABLE TO FINISH CORING THE TUNNEL. SURGEON HAD TO OPEN A THIRD FLIPCUTTER II TO COMPLETE CASE SUCCESSFULLY; PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460257 ↗
• MalfunctionApr 19, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION PROCEDURE, THE AR-1204AS-105, WOULD NOT FLIP BACK AFTER THE FEMORAL TUNNEL WAS DRILLED, AND THE SURGEON SPENT SIGNIFICANT AMOUNT OF TIME TRYING TO PRY IT BACK MANUALLY IN THE JOINT. EVENTUALLY THE SURGEON WAS ABLE TO GET IT ALMOST VERTICAL (BUT NOT FULLY) AND REMOVE IT FROM THE FEMORAL TUNNEL. THE CASE WAS COMPLETED BY USING ANOTHER FLIPCUTTER IN ORDER TO DRILL THE TIBIAL TUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142187 ↗
• MalfunctionMar 27, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-105 FLIPCUTTER II HAD AN ISSUE. THE TIP BROKE OFF DURING A CASE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618652 ↗
• MalfunctionMar 28, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-105 FLIP-CUTTER II BROKE DURING A CASE. ALL WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 13929011 ↗
• MalfunctionJan 31, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1204AS-105 FLIPCUTTER, FLIPPED CUTTING THE FEMUR AND BROKE. THIS WAS DISCOVERED DURING USE IN A ACL W/ MENISCAL REPAIR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 13397587 ↗
• MalfunctionOct 19, 2021Mechanical Problem; Unintended Movement

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT QTY.2 OF AN AR-1204AS-105 FLIPCUTTER BROKE DURING A KNEE ACL RECONSTRUCTION. THE FIRST FLIPCUTTER WAS FLIPPED IN THE KNEE TO RETRODRILL A TIBIAL TUNNEL AND UPON DEPLOYMENT OF THE CUTTER, THE BLADE SHOT OFF THE INSTRUMENT AND INTO THE JOINT. THE FRAGMENT WAS REMOVED AND A SECOND FLIPCUTTER WAS UTILIZED. WHEN THE SURGEON WAS USING THE SECOND FLIP CUTTER, IT WAS SELF DEPLOYING IN THE KNEE POST RETROGRADE FLIPPING. THE MECHANISM WOULD NOT LOCK THE CUTTER STRAIGHT FOLLOWING DEPLOYMENT, AND WAS FLIPPING SPONTANEOUSLY IN THE JOINT UPON RETRACTION. THE CASE WAS COMPLETED BY USING A THIRD AR-1204AS-105.

  Patient problems: Failure of Implant

  MAUDE report 12659181 ↗
• MalfunctionMay 18, 2021Break

  IT WAS REPORTED DURING A ACL RECONSTRUCTION PROCEDURE, THE TIP OF THE AR-1204AS-105 FIPCUTTER BROKE AS THE SURGEON WAS MAKING THE TUNNEL. ALL FRAGMENTS WERE FULLY RETRIEVED. A SECOND FILPCUTTER WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11841580 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT THE DRILL GUIDE HIT THE TIP OF THE AR-1204AS-105 FLIPCUTTER II AND THE TIP BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629849 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-1204AS-105 FLIPCUTTER II BROKE OFF INSIDE THE PATIENT'S KNEE. ALL BROKEN PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11629760 ↗
• InjuryOct 31, 2017Break

  IT WAS REPORTED THAT THE BASE OF THE SHAFT OF THE CUTTER BROKE OFF DURING THE BACK DRILLING OF THE PCL TIBIAL TUNNEL. IT WAS UNFLIPPED AND REMOVED; THE TECHNIQUE WAS CHANGED AND THEY DRILLED A FULL TUNNEL TO COMPLETE THE CASE. PATIENT IS MALE (B)(6).FOLLOW-UP INVESTIGATION: THE PLANNED PROCEDURE WAS A PCL GRAFTLINK. SURGEON HAD TO MANUALLY UNFLIP THE BROKEN FLIPCUTTER II TO GET THE DEVICE AND FRAGMENT, FROM THE BASE OF THE DEVICE SHAFT, OUT OF THE PATIENT, WHICH CAUSED A DELAY OF APPROXIMATELY 20 MINUTES. NO EXTRA UNPLANNED INCISIONS WERE NEEDED. SURGEON CHANGED TECHNIQUE BY DRILLING A FULL TUNNEL. IT WAS THE INNER SLEEVE OF THE FLIPCUTTER THAT BROKE AT THE BASE. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6991284 ↗