Arthrex® AR-1204AF-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867004139), received between Apr 4, 2017 and Jan 16, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE FLIPCUTTER BROKE INTO TWO PIECES WHEN ENCOUNTERING A HARD BONE. THE SURGEON REMOVED ALL FRAGMENTS 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 24092303 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE DEVICE BROKE OFF. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-1204FF. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22227289 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE TIP OF THE DEVICE BROKE OFF. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER AR-1595TC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210464 ↗
• 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 15445979 ↗
• MalfunctionJun 6, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE BROKE DURING DRILLING INWARD INTO THE JOINT. 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 14602060 ↗
• MalfunctionMay 31, 2022Break; Material Twisted/Bent

  ON 05/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING A PCL RECONSTRUCTION PROCEDURE, WHEN THE SURGEON WAS DRILLING THE FEMORAL TUNNEL WITH AN AR-1204AF-110 FLIPCUTTER, THE TIP STRUCK THE TOP OF THE FEMORAL NOTCH AND THE FLIPCUTTER SPLIT OPEN AND BROKE. THE TIP WAS RETRIEVED FROM THE PATIENT AND THEN AN AR-1204AF-105 FLIPCUTTER WAS USED AND DURING USE THE TIP BENT. THE CASE WAS COMPLETED BY USING A THIRD FLIPCUTTER WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548318 ↗
• MalfunctionJan 11, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) ALL-INSIDE SURGERY THE DEVICE BROKE OFF IN THE PATIENT, IN THE MIDDLE OF BACKWARD DRILLING. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225842 ↗
• MalfunctionOct 12, 2021Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE CRUCIATE LIGAMENT SURGERY WHILE INSERTING THE FLIPCUTTER IN THE DRILL HOLE THE DEVICE BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART AND REPORTED THAT THE BONE OF THE PATIENT WAS VERY HARD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THEREFORE THE IMPLANT HAS TO BE MADE SMALLER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12616895 ↗
• InjuryDec 1, 2017Material Fragmentation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE THREE DIFFERENT FLIP CUTTER II'S WERE ATTEMPTED (AR-1204AF-100: LOT 415148483 {LINE 213291}, LOT 74071209 {LINE 213292} AND AR-1204AF-110: LOT 62316678 {LINE 213294}) AND EACH BROKE INTRA-ARTICULAR WHEN STARTING THE BLIND TUNNEL. BROKEN FRAGMENTS WERE ALL REPORTED TO HAVE BEEN RETRIEVED. THE SURGICAL TECHNIQUE WAS CHANGED FROM AN ACL TO AN ARTHROTOMY AND THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7074414 ↗
• InjuryApr 18, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY CASE, THE TIP BROKE OFF OF THE 11.0 MM FLIP CUTTER. THE TIP BROKE OFF INTO 2 PIECES HOWEVER ONLY ONE PIECE WAS ABLE TO BE RETRIEVED. THE SURGEON ATTEMPTED TO GRASP THE SECOND PIECE (APROX 2 MM) WITH A GRASPER BUT WAS UNSUCCESSFUL. ANOTHER 11.0 MM FLIP CUTTER WAS OPENED AND USED TO COMPLETE THE CASE. SALES REP REPORTED THAT THE SURGEON WAS NOT CONCERNED WITH THE LOCATION WHERE THE UN-RETRIEVED DEVICE FRAGMENT IS LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6499730 ↗
• InjuryApr 4, 2017Break; Component Falling

  IT WAS REPORTED THAT DURING AN ACL TIBIAL TUNNEL DRILLING, THE FLIP CUTTER II BROKE AND A PIECE STAYED INSIDE THE PATIENT. USED ANOTHER FLIP CUTTER SIZE 10 AND COMPLETED THE CASE SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. CASE: ACL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6457364 ↗