Arthrex® AR-8400CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867043497), received between Nov 15, 2018 and Dec 16, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400CDS DISSECTOR HAD SMALL PIECES OF METAL INTRODUCED INTO THE JOINT FROM THE SHAVER. UPON EXAMINATION OF THE SHAVER, THERE WERE LINES ON THE ACTUATING PORTION OF THE DEVICE. THIS WAS DISCOVERED DURING A KNEE ARTHROSCOPY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816606 ↗
• MalfunctionJan 14, 2025Material Fragmentation; Material Fragmentation

  ON 12/18/2024 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA SEMS-06738194, THAT AN AR-8400CDS DISSECTOR WAS PRODUCING METAL SHAVINGS. THIS OCCURRED DURING A KNEE PROCEDURE WHEN THE SHAVINGS STARTED FALLING INTO THE KNEE. ALL THE SHAVINGS WERE REMOVED FROM THE PATIENTS KNEE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148779 ↗
• MalfunctionJan 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SHAVER LEFT RESIDUES DURING ACTIVATION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ON 09-OCT-2023, UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE CUSTOMER TRIED TO REMOVE THE DEBRIS BUT WAS NOT 100% SURE IF EVERYTHING COULD BEEN RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113141 ↗
• MalfunctionNov 3, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 10/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06056928 THAT AN AR-8400CDS DISSECTOR WAS PUSHED DOWN AND THE TEETH WERE BENT IN, IT WOULD NOT ROTATE WHEN TRYING TO ENGAGE. THIS OCCURRED DURING A CASE WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066788 ↗
• MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SHAVER LEFT RESIDUES DURING ACTIVATION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. (B)(6) 2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE CUSTOMER TRIED TO REMOVE THE DEBRIS BUT WAS NOT 100% SURE IF EVERYTHING COULD BEEN RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18004503 ↗
• MalfunctionMar 15, 2023Break; Break

  ON 02/20/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-8400CDS DISSECTOR BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2022 WHEN THE SHAVER STARTED TO WORK AND IMMEDIATELY STOPPED AS IF IT GOT STUCK. WHEN ATTEMPTING TO REMOVE IT THE AR-8400CDS BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 16544440 ↗
• MalfunctionDec 12, 2022Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8400CDS DISSECTOR CAUSED METAL SHAVINGS WHEN USED. CASE INVOLVEMENT, DEVICE BROKE DURING USE, FRAGMENTS UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15959686 ↗
• MalfunctionJan 4, 2022Break

  IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8400CDS DISSECTOR SNAPPED AT THE CURVE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152638 ↗
• InjuryNov 15, 2018Material Disintegration

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR UPON INSERTION THE AR-8400CDS WAS PRODUCING METAL SHAVING. THE SURGEON CHANGED THE AR-8400CDS SAME LOT NUMBER (10212946) AND THE PROBLEM OCCURRED AGAIN. THE SURGEON USED A SHAVER TO SUCTION THE METAL SHAVING, THE SALES REP WAS UNSURE IF ALL THE METAL SHAVING WERE REMOVED. NO X-RAY WAS TAKING AFTER THE PROCEDURE WAS COMPLETE. THE CASE WAS COMPLETED USING A THIRD AR-8400CDS WITH NO ADDITIONAL ISSUE.

  Patient problems: No Code Available

  MAUDE report 8074735 ↗