Arthrex® AR-1204AF-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867004238), received between Dec 21, 2021 and Mar 5, 2024 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PLUS OSTEOTOMY SURGERY AFTER INSERTION INTO THE TISSUE, THE DRILLING TIP OF THE RETROGRADE DRILL BROKE OFF. ALL FRAGMENTS WERE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839178 ↗
• InjuryMay 30, 2023Retraction Problem; Retraction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A AR-1204AF-75 (7.5 MM FLIP CUTTER II) WAS UNABLE TO BE UN-FLIPPED AFTER IT HAS BEEN FLIPPED IN THE PATIENT'S KNEE. THIS OCCURRED DURING USE IN AN ACL PROCEDURE ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM, AFTER REAMING FULL TIBIA TUNNEL INSTEAD OF RETROGRADE DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022970 ↗
• MalfunctionNov 9, 2022Disconnection; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION ALL-INSIDE SURGERY THE OUTSIDE PART OF THE FLIPCUTTER CAME OFF THE DEVICE DURING DRILLING. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 26-OCT-2022: FURTHER INFORMATION REVEALED THAT THE FLIPCUTTER HAS 2 PARTS: AN INSIDE WIRE AND AN OUTSIDE WIRE. THE OUTSIDE PART GOT LOOSE FROM THE INSIDE PART AT THE END OF THE BLUE PART AND IT SLID OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758810 ↗
• MalfunctionDec 21, 2021Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE ANTERIOR CRUCIATE LIGAMENT ARTHROSCOPIC KNEE SURGERY THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT DURING DRILLING. NO BROKEN PARTS REMAINED INSIDE 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 13053876 ↗