Arthrex® AR-8400EXRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888867043589), received between Dec 13, 2017 and Sep 28, 2026 — classified as 5 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (13 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported that during an arthroscopy surgery the outer shell of the device broke. The breakage point was outside the patient, and no fragments had to be retrieved 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 50913601 ↗
• MalfunctionJan 13, 2026Break

  ON 31-DEC-2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-8400EX EXCALIBUR TIP BROKE THE TOOTH INTO TWO PARTS DURING A CASE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053218 ↗
• MalfunctionDec 9, 2025Break; Break

  ON 11/20/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400EX EXCALIBUR BROKE OFF. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757857 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 4TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8400EX, EXCALIBUR, 4.0 MM X 13 CM, IT WAS BENT WHEN USING IT TO DO SYNOVIAL MEMBRANE CLEANING. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-8400EX. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629985 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-8400EX EXCALIBUR BLADE/BURR WAS BENT IN A ROTATOR CUFF SURGERY WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406015 ↗
• MalfunctionOct 27, 2025Material Fragmentation; Material Fragmentation

  ON 10/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8400EX EXCALIBURS HAD METAL SHAVING DEBRIS DURING USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM REP ON 10/15/2025 STATING THAT DEBRIS WAS PRODUCED INSIDE PATIENT BUT THE FRAGMENTS WERE ALL REMOVED. THERE WERE NO PHOTOS AVAILABLE AND THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389583 ↗
• MalfunctionOct 27, 2025Material Fragmentation; Material Fragmentation

  ON 10/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8400EX EXCALIBURS HAD METAL SHAVING DEBRIS DURING USE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM REP ON (B)(6) 2025 STATING THAT DEBRIS WAS PRODUCED INSIDE PATIENT BUT THE FRAGMENTS WERE ALL REMOVED. THERE WERE NO PHOTOS AVAILABLE AND THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389567 ↗
• MalfunctionSep 2, 2025Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  ON 15TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-8400EX, EXCALIBUR, 4.0 MM X 13 CM, THE HANDLE WAS OVERHEATED, RESULTING IN THE DEFORMATION OF THE CONNECTION BETWEEN THE GRINDING HEAD(AR-8400EX) AND THE HANDLE. AS A RESULT, THE PRODUCT CANNOT BE USED NORMALLY. THIS WAS DETECTED DURING AN ARTHROSCOPIC EXPLORATION AND INTERNAL FIXATION OF ACROMIOCLAVICULAR JOINT DISLOCATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-8400EX. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945546 ↗
• MalfunctionJul 30, 2025Material Fragmentation; Material Fragmentation

  ON 07/07/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8400 EX EXCALIBUR HAD METAL SHAVINGS FLAKED OFF INSIDE OF THE JOINT (SHOULDER) DURING A SHOULDER ARTHROSCOPY ON 7/7/2025. THE ISSUE WAS NOTICED DURING THE PROCEDURE. NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663326 ↗
• MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation

  ON 02/18/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400EX EXCALIBUR BEGAN TO PRODUCE DEBRIS DURING USE. THIS WAS DISCOVERED DURING USE IN AN ARTHROSCOPY CASE. THE FRAGMENTS WERE UNABLE TO BE REMOVED. THE CASE WAS COMPLETED USING A REPLACEMENT PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22056041 ↗
• MalfunctionFeb 26, 2025Material Fragmentation; Material Fragmentation

  ON 02/18/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400EX EXCALIBUR BEGAN TO PRODUCE DEBRIS DURING USE. THIS WAS DISCOVERED DURING USE IN AN ARTHROSCOPY CASE. THE FRAGMENTS WERE UNABLE TO BE REMOVED. THE CASE WAS COMPLETED USING A REPLACEMENT PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21471704 ↗
• MalfunctionSep 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE PRODUCED METAL SHAVINGS. THE KNEE WAS FLUSHED OUT BUT THE CUSTOMER WAS NOT SURE IF EVERYTHING COULD BE REMOVED. 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 20202142 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  ON 07/26/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-(B)(4) THAT AN AR-8400EX EXCALIBUR WAS PRODUCING SMALL METAL FRAGMENTS THAT WERE BEING EMBEDDED IN TISSUE. THIS OCCURRED DURING A KNEE SCOPE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20030295 ↗
• MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation

  ON 07/26/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-(B)(4) THAT AN AR-8400EX EXCALIBUR WAS PRODUCING SMALL METAL FRAGMENTS THAT WERE BEING EMBEDDED IN TISSUE. THIS OCCURRED DURING A KNEE SCOPE.

  Patient problems: Insufficient Information

  MAUDE report 19962503 ↗
• MalfunctionJun 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/23/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06576985 THAT AN AR-8400EX EXCALIBUR HAD A BLACK OBJECT DETACH FROM THE INSIDE OF THE SHAVER DURING INITIAL STARTUP. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19573844 ↗
• MalfunctionMay 22, 2024Break; Break

  ON 03/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-8400EX EXCALIBURS SHAVER BLADE BECAME DAMAGED. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369356 ↗
• MalfunctionMay 9, 2024Material Fragmentation; Material Fragmentation

  ON 04/16/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06541006 THAT AN AR-8400EX EXCALIBUR WAS PRODUCING DEBRIS. THIS OCCURRED DURING A KNEE ARTHROSCOPY PROCEDURE WHEN THE OSCILLATING TEETH COLLIDED WITH THE SLEEVE OF THE BLADE ITSELF, PRODUCING DEBRIS. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19277470 ↗
• MalfunctionMay 7, 2024Defective Device; Defective Device

  ON 4/14/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400EX EXCALIBUR INNER CYLINDER OF THE BLADE WAS SLIGHTLY BENT. SURGEON USED A NEW PRODUCT AND CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260291 ↗
• MalfunctionMar 17, 2023Material Fragmentation; Material Fragmentation

  ON 6/30/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8400EX EXCALIBUR PRODUCED DEBRIS. THE SURGEON PLACED IT IN THE HANDPIECE AND STARTED RESECTING THE TISSUE WHEN THE BLADE RELEASE DEBRIS IN THE JOINT. THE EXCALIBUR WAS REMOVED FROM INSIDE THE PATIENT AND WITH THE HELP OF ASPIRATION AND WASHING CLEAN THE JOINT SPACE, THE SURGEON WAS ABLE TO GET RID OF ALL THE RESIDUE. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 7/5/2022: THE CASE WAS COMPLETED WITH ANOTHER AR-8400EX EXCALIBUR AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16563754 ↗
• MalfunctionMar 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY DEBRIS WAS PRODUCED INSIDE THE KNEE. IT WAS FURTHER REPORTED THAT THE METAL DEBRIS WAS REMOVED. THERE WAS NO HARM TO THE 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.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552666 ↗
• MalfunctionMar 2, 2023Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR AND ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 16466159 ↗
• MalfunctionNov 16, 2021Disconnection

  ON 11/02/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400OEX EXCALIBUR, CUTTER HEAD IS PARTIALLY DISCONNECTED. THIS WAS DISCOVERED DURING USE IN A KNEE PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY SWAPPING OUT THE AR-8400EX.

  Patient problems: Insufficient Information

  MAUDE report 12822237 ↗
• MalfunctionFeb 22, 2021Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR, THE AR-8400EX BROKE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-8400EX WITHOUT FURTHER ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 11357694 ↗
• InjuryOct 22, 2019Material Fragmentation

  IT WAS REPORTED DURING A KNEE ARTHROSCOPY WITH MENISECTOMY PROCEDURE THE SURGEON NOTICED METAL SHAVINGS FLOATING IN THE JOINT SPACE WHILE USING THE AR-8400EX, EXCALIBUR. THE ISSUE OCCURRED AS THE SURGEON WAS SHAVING THE MENISCUS. THE SHAVINGS WERE SUCKED OUT WITH THE SHAVER AND THE CASE WAS COMPLETED. THE REP STATED A SECOND DEVICE WAS NOT NEEDED, AND THERE WAS NO HARM OR INJURY TO THE PATIENT. THE BONE QUALITY WAS MEDIUM. DUALWAVE OUTFLOW WAS NOT BEING USED. THE REP STATED THERE WAS NOT AN ARTHREX REP PRESENT DURING THE PROCEDURE, AND THE SURGEON INFORMED THEM OF THE ISSUE POST-OP. THE REP REPORTED THE ISSUE HAS BEEN OCCURRING ACROSS DIFFERENT LOTS AND PART NUMBERS BUT THE ISSUE HAS BEEN PRIMARILY WITH AR-8400EX, (LOT: 10324466). ADDITIONAL INFORMATION RECEIVED ON 10/02/2019: THE REP REPORTED THE SURGEON DID THEIR BEST TO REMOVE ALL THE SHAVINGS, BUT IT CANNOT BE CONFIRMED THAT ALL SHAVINGS WERE FULLY REMOVED. THE COMPLAINT DEVICE IS AVAILABLE TO RETURN FOR EVALUATION. THE REP STATED THERE IS NO AVAILABLE INFORMATION WITH REGARD TO OTHER ARTHREX DEVICES MALFUNCTIONING AS ARTHREX REPRESENTATIVES WERE NOT PRESENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9219983 ↗
• InjurySep 4, 2019Material Fragmentation

  IT WAS REPORTED THAT A 4.0MM OVAL BURR, AR-8400OBE, AND A 4.0MM EXCALIBUR, AR-8400EX, WERE BEING USED DURING A SHOULDER ARTHROSCOPY PROCEDURE. DURING USE, EITHER THE 4.0 EXCALIBUR OR 4.0 OVAL BURR LEFT FLAKES IN THE JOINT. THE REP WAS UNABLE TO DETERMINE WHICH DEVICE THE FLAKES CAME FROM. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: THE FLAKES APPEARED DURING SAD. THE PATIENT HAD NORMAL QUALITY TISSUE. THE FLAKES WERE NOT ABLE TO BE FULLY REMOVED FROM THE JOINT. DUALWAVE OUTFLOW TUBING WAS NOT USED IN THE CASE AND THERE WAS AN UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE DURING ITS USE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8961070 ↗