Arthrex® AR-8400DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867043572), received between Aug 17, 2021 and Sep 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924014 ↗
• MalfunctionMar 16, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, THE DEVICES DID NOT ROTATE FREELY AND ESPECIALLY ONE AR-8400DS WAS DIFFICULT TO ROTATE. THE SURGEON SWITCHED BACK AND FORTH BETWEEN THE TWO SHAVERS BECAUSE BOTH ONLY EVER REMOVED A MINIMAL AMOUNT OF MATERIAL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES WERE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605837 ↗
• MalfunctionMar 16, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, THE DEVICES DID NOT ROTATE FREELY AND ESPECIALLY ONE AR-8400DS WAS DIFFICULT TO ROTATE. THE SURGEON SWITCHED BACK AND FORTH BETWEEN THE TWO SHAVERS BECAUSE BOTH ONLY EVER REMOVED A MINIMAL AMOUNT OF MATERIAL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES WERE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605714 ↗
• MalfunctionDec 11, 2024Break; Break

  ON 11/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400DS DISSECTOR SHAVER TOOTH BROKE DURING A KNEE SCOPE PROCEDURE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907055 ↗
• MalfunctionMay 8, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT THE PICTURE OF THE SHAVER BLADE IS MISSING ON THE LABEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD-PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274797 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THERE WAS METAL ABRASION WITH TWO SHAVER BLADES. 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 19188537 ↗
• MalfunctionApr 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THERE WAS METAL ABRASION WITH THE TWO SHAVER BLADES. 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 19183195 ↗
• MalfunctionApr 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING KNEE ASK SURGERY BOTH DEVICES ARE DEFECTIVE. 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 19134279 ↗
• MalfunctionJan 3, 2024Break; Break

  ON 12/5/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400DS DISSECTOR TIP CHIPPED OFF WHILE BEING USED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437027 ↗
• MalfunctionSep 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SHAVER ATTACHMENT PRODUCED METAL DEBRIS. IT WAS POSSIBLE TO REMOVE THE METAL DEBRIS FROM THE PATIENT BY RINSING. 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 17839249 ↗
• MalfunctionSep 19, 2023Material Erosion; Material Fragmentation; Material Erosion; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY METAL ABRASION OCCURRED WITH THE DEVICES AR-8400DS (LOT: 15107563) ALREADY AFTER A VERY SHORT TIME DURING SURGERY. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE 05-SEP-2023. IT WAS CONFIRMED THAT ALL FRAGMENTS COULD BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775599 ↗
• MalfunctionSep 19, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT METAL DEBRIS WAS PRODUCED IN COMBINATION WITH THE DEVICE. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE (B)(6) 2023. IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SHOULDER ARTHROSCOPY. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 17775443 ↗
• MalfunctionDec 21, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8400DS SHAVER DISSECTOR BROKE DURING A ROTATOR CUFF PROCEDURE. THE SHAFT BROKE AT THE PROXIMAL END WHILE RESECTING. ALL PIECES WERE RECOVERED. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 13054567 ↗
• MalfunctionAug 31, 2021Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2021, THE SHAFT WAS BENT DURING DIRECT PATIENT INTERACTION AND METAL POWDER ENTERED THE PATIENT'S BODY. THE SURGEON ATTEMPTED TO REMOVE THE POWDER, BUT WAS UNABLE TO CONFIRM THAT ALL POWDER HAD BEEN REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PRODUCT, WHICH WAS DISCARDED BY THE FACILITY AFTER USE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12393743 ↗
• MalfunctionAug 31, 2021Material Fragmentation

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8400DS, DISSECTOR, WAS HITTING THE HOOD UPON OPENING AND DEPOSITING METAL SHAVINGS IN THE JOINT. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. THE PROCEDURE WAS STOPPED FOR 2 MINUTES TO REPLACE THE DEVICE AND THE CASE WAS COMPLETED WITH A NEW AR-8400DS FROM THE SAME LOT.

  Patient problems: Insufficient Information

  MAUDE report 12393110 ↗
• MalfunctionAug 17, 2021Break

  IT WAS REPORTED THAT DURING MENISCAL SURGERY THE SHAVER BLADE 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: Insufficient Information

  MAUDE report 12333051 ↗