Arthrex® AR-8400DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867043565), received between Mar 5, 2019 and Feb 12, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Material Fragmentation; Defective Device; Material Fragmentation; Defective Device

  ON 01/22/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO BOXES OF (QTY.5) AR-8400DC 4MM X 13CM DOUBLECUTS HAVE EXTRA PIECES OF METAL AT THE END OF TIP. THEY WERE INVOLVED IN A CASE AND THE PATIENT WAS NOT HARMED. THEY WERE ABLE TO REMOVE EXCESS METALS FROM INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364826 ↗
• MalfunctionFeb 10, 2025Material Fragmentation; Material Fragmentation

  ON 01/22/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO BOXES OF (QTY.5) AR-8400DC 4MM X 13CM DOUBLECUTS HAVE EXTRA PIECES OF METAL AT THE END OF TIP. THEY WERE INVOLVED IN A CASE AND THE PATIENT WAS NOT HARMED. THEY WERE ABLE TO REMOVE EXCESS METALS FROM INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349407 ↗
• InjuryJun 16, 2020Material Fragmentation

  IT WAS REPORTED DURING A SHOULDER ARTHROSCOPY THE SHAVER BLADE PRODUCED SHAVINGS INSIDE THE PATIENT. THIS OCCURRED WHEN THE DOCTOR STARTED THE SHAVING PROCESS. HE PULLED THE SHAVER RIGHT AWAY AND RINSED THE AREA. THE DOCTOR CONFIRMED ALL VISIBLE FRAGMENTS WERE REMOVED. THERE WAS NO X-RAY TAKEN. A SECOND BLADE WAS USED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO SIGNS OF SHAVINGS OR DEBRIS FROM THE SECOND BLADE. THE PATIENT IS FINE TO DATE PER CALLER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10157847 ↗
• InjuryJun 27, 2019Peeled/Delaminated

  IT WAS REPORTED DURING A SHOULDER ARTHROPLASTY PROCEDURE THE AR-8400OBE OVAL BURR, AND AR-8400DC DOUBLE CUT WERE LEAVING METAL SHAVINGS IN THE SHOULDER POST ACROMIOPLASTY. THE REP STATED IT IS UNKNOWN IF ONLY THE AR-8400OBE WAS PRODUCING SHAVINGS, OR IF BOTH DEVICES WERE. THE DEBRIS BEING PRODUCED WERE BETWEEN THE SIZE OF POWDER AND SHAVINGS. THE CASE WAS COMPLETED BY USING SUCTION ON THE AR-8400DC TO REMOVE THE SHAVINGS. THE REP STATED IT SEEMED AS THOUGH ALL SHAVINGS WERE REMOVED. HOWEVER, IT CANNOT BE CONFIRMED IF ALL SHAVINGS WERE FULLY SUCTIONED OUT OF THE JOINT. NO OTHER BURRS WERE OPENED. THE SPEED OF THE CONSOLE WAS SET AT 6200 RPM. SUCTION ON THE HANDPIECE WAS SET AT 450 MMHG, AND THE DISPOSABLE WAS IN REVERSE. NO OUTFLOW TUBING WAS USED, AND SUCTION WAS ON THROUGH HANDPIECE DURING ACROMIOPLASTY. THE BONE QUALITY WAS MEDIUM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8739476 ↗
• InjuryJun 26, 2019Corroded

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE SURGEON WAS DOING A DECOMPRESSION AND THE OVAL BURR, AR-8400OBE WAS PRODUCING METAL FLAKES IN THE JOINT. NO FURTHER INFORMATION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 6/12/2019: THE SHAVINGS LOOKED LIKE GLITTER IN THE JOINT AND WERE PROBABLY NOT RETRIEVED. THE CASE WAS COMPLETED WITH A NEW SHAVER. ADDITIONAL INFORMATION PROVIDED 6/13/2019: THE ACCOUNT HAS TWO BLADES FROM THE CASE. THEY ALSO USED AN AR-8400DC, LOT: 10274224. IN ADDITION TO THE AR-8400OBE AND THEY AREN¿T 100% SURE WHICH ONE PRODUCED THE METAL FLAKES, SO THEY SAVED BOTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735392 ↗
• InjuryMar 5, 2019Material Fragmentation; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF A SHOULDER SCOPE PROCEDURE AS THE SURGEON PLACED THE AR-8400DC, DOUBLECUT INTO THE JOINT AND STARTED OSCILLATING, METAL FLAKES STARTED FLOWING INTO THE JOINT SPACE. THE REP REPORTED IT APPEARED AS THOUGH METAL FLAKES WERE ALREADY SITTING IN THE CHAMBER OF THE SHAVER. THE SURGEON ATTEMPTED TO SUCTION OUT ALL OF THE METAL DEBRIS. THE REP STATED THEY CANNOT CONFIRM IF ALL METAL FLAKES WERE FULLY SUCTIONED OUT AS THERE WERE MANY OF THEM AND THE FLAKES WERE VERY SMALL (APPROXIMATELY A MILLIMETER OR LESS). THE DEVICE WILL NOT BE RETURNING FOR EVALUATION AS IT WAS DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION RECEIVED ON 2/19/2019: THE REP REPORTED THAT THE CASE WAS COMPLETED BY SUCTIONING OUT AS MANY FLAKES AS POSSIBLE, AND A SECOND AR-8400DC FROM THE SAME LOT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8390785 ↗