Arthrex® AR-1204.5LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867004009), received between Apr 18, 2018 and Sep 21, 2021 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Break

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY SURGERY THE CANNULATED DRILL DID BREAK OFF. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506571 ↗
• InjuryApr 18, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE 4.5MM CANNULATED DRILL HAS A BROKEN TIP. NO FURTHER DETAILS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. FOLLOW-UP INVESTIGATION: THE SURGEON WAS PERFORMING A DEEP DELTOID LIGAMENT RECONSTRUCTION THROUGH BONY TUNNELS WITH HAMSTRING AUTOGRAFT PROCEDURE AND AS SHE WAS DRILLING INTO A SPACE WITH EXISTING HARDWARE, SHE HIT A SCREW. THE TIP OF THE DRILL BROKE-OFF AND WAS LEFT IN BONE, AS A BROKEN SCREW WOULD BE. ONLY THE BASE OF THE DRILL WILL BE RETURNED FOR EVALUATION, THE TIP WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7439293 ↗