Arthrex® AR-8400CEXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867043503), received between Dec 28, 2018 and Jan 2, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Use of Device Problem

  IT WAS REPORTED DURING THE KNEE ARTHROSCOPY THAT THE DEVICE STOPPED WORKING DURING NORMAL USE WITHOUT ANY FORCE BEING APPLIED. 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 23945759 ↗
• MalfunctionOct 17, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT DURING A SURGERY THE SHAVER BLADE GOT BLOCKED INTRAOPERATIVE NOT ALLOWING FOR FLUIDS AND DISINTEGRATED TISSUE TO BE REMOVED VIA THE SUCTION TUBE PORT. DUE TO THIS ISSUE UNNECESSARY PRESSURE AND FLUID OVERLOADING IN THE KNEE WAS THE RESULT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation

  MAUDE report 23322545 ↗
• MalfunctionMar 26, 2025Break; Break

  ON 03/06/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8400CEX EXCALIBUR SNAPPED DURING A CASE. THE CURVED BLADE WAS USED FOR SOME SHAVING AND THEN TO BURN MODE. IT WAS 1/2 INCH BELOW THE BLADE CURVE WHEN IT SNAPPED BETWEEN BONE. NO PATIENT WAS AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/17/2025: AR-8400CEX EXCALIBUR DID PRODUCE DEBRIS AND BREAK. ALL FRAGMENTS WERE RETRIEVED. THERE WAS A 60-90-SECOND CASE DELAY TO OPEN A NEW SHAVER BLADE. THE CASE CONTINUED AS PLANNED, AND ANOTHER AR-8400CEX WAS USED TO COMPLETE IT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WERE NO ADVERSE EFFECTS DURING OR AFTER THE SURGERY. THIS OCCURRED DURING A MEDIAL PATELLOFEMORAL REPAIR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699509 ↗
• MalfunctionDec 12, 2024Material Fragmentation; Material Fragmentation

  ON 11/18/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400CEX EXCALIBUR HAD METAL SHAVINGS COME OFF A SHAVER PIECE. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912665 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  IT WAS REPORTED BY A SALES REP THAT THE AR-8400CEX, IS LABELED INCORRECTLY. THE PACKAGING IS LABELED AS AR-8400CEX (EXCALIBUR, CURVED) BUT THE DEVICE IS STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190664 ↗
• MalfunctionJul 11, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8400CEX EXCALIBUR BROKE WHILE PREFORMING A MEDIAL MENISCECTOMY. THE EXCALIBUR BROKE WHILE INSIDE THE SHEATH AND ALL THE BROKEN FRAGMENTS WERE ACCOUNTED FOR. A NEW AR-8400CEX EXCALIBUR WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A MENISCECTOMY PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976665 ↗
• MalfunctionJul 11, 2022Break

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8400CEX EXCALIBUR BROKE WHILE CLEANING UP THE TIBIAL STUMP. THE EXCALIBUR BROKE WHILE INSIDE THE SHEATH AND ALL THE BROKEN FRAGMENTS WERE ACCOUNTED FOR. A NEW AR-8400CEX EXCALIBUR WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6)2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976660 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED DURING A KNEE SCOPE THE SHAVER BURR BROKE. IT WAS REPLACED AND THE SAME EVENT OCCURRED. IT WAS REPLACED A THIRD TIME AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. EVERYTHING WAS RETRIEVED AND THE PATIENT IS FINE TO DATE. THE CALLER HAD NO FURTHER DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 11947464 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED DURING A KNEE SCOPE THE SHAVER BURR BROKE. IT WAS REPLACED AND THE SAME EVENT OCCURRED. IT WAS REPLACED A THIRD TIME AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. EVERYTHING WAS RETRIEVED AND THE PATIENT IS FINE TO DATE. THE CALLER HAD NO FURTHER DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 11947449 ↗
• InjurySep 10, 2019Material Fragmentation; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THERE WAS A STRONG ABRASION OF THE METAL. ALSO IT WAS NOT POSSIBLE ANYMORE TO ATTACH THE DEVICE ONTO THE SHAVER HANDPIECE CAUSE THE O-RING BECAME LOOSE. ACCORDING TO THE SURGEON THERE ARE NO BROKEN PARTS REMAINING INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE OF THE SAME PART NUMBER. THERE WAS NO ADVERSE EVENT REPORTED BY THE CUSTOMER. UPDATE 20-AUG-2019: AFTER CONTACTING THE SURGEON TO VERIFY THAT THERE ARE NO METAL FRAGMENTS REMAINING INSIDE THE PATIENT, HE COULD NOT CONFIRM IT. ACCORDING TO THE SURGEON THERE IS A POSSIBILITY THAT THERE ARE STILL METAL ABRASIONS INSIDE THE JOINT OF THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8980944 ↗
• InjuryMay 16, 2019Failure to Cut

  IT WAS REPORTED THAT DURING A ARTHROSCOPY THE ITEM AR8400CEX WAS NOT SHARP ENOUGH TO CUT THE TISSUE IT WAS NECESSARY TO CHANGE THE DULL ITEM. THIS DOES NOT ONLY REQUIRE TIME, BUT CAUSED ALSO ADDITIONAL MANIPULATIONS IN THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615099 ↗
• InjuryDec 28, 2018Failure to Deliver Energy; Overheating of Device

  IT WAS REPORTED THAT THE AR-8400CEX, EXCALIBUR BLADE STOPPED TURNING/OSCILLATING DURING DEBRIDEMENT AT THE VERY END OF A KNEE SCOPE PROCEDURE. THE FACILITY STATES THAT THE DEVICE OVERHEATED, AND BURNED THE PATIENT AT THE PORTAL SITE. THE REP STATED THERE WAS NOT A CANNULA USED, AND THE SHAVER BLADE MADE DIRECT CONTACT WITH THE PATIENT'S SKIN. THE REP CONFIRMED THAT THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE PROCEDURE. THE REP STATED THAT THE CASE WAS COMPLETED, AND A NEW AR-8400CEX WAS NOT NEEDED AS THE SURGICAL STEP HAD BEEN COMPLETED. THE FACILITY INFORMED THE REP THAT THERE IS A FOLLOW-UP VISIT SCHEDULED WITH THE PATIENT ON (B)(6) 2018 TO RE-BANDAGE AND ASSESS THE BURN WOUND. UPDATE (B)(4) 2018: AT TIME OF REPORT TO THE FDA FURTHER INFORMATION WITH REGARD TO THE PATIENT FOLLOW UP VISIT WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Burn, Thermal

  MAUDE report 8202824 ↗