Arthrex® AR-8400CTDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867187801), received between Apr 12, 2021 and Apr 10, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING THE MENISCECTOMY, THE DEVICE BROKE AT THE POINT WHERE THE STRAIGHT SECTION TRANSITIONS INTO A CURVED SECTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845168 ↗
• MalfunctionAug 14, 2025Premature Separation; Premature Separation

  ON 07/29/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8400CTD TORPEDO DISASSEMBLED. THIS OCCURRED DURING USE WHEN THE CONSUMABLE WAS PASSED TO BE PLACED IN THE HANDPIECE, IT WAS DISASSEMBLED. AN ATTEMPT WAS MADE TO USE IT, BUT IT WAS NOT STABLE AND DID NOT PERFORM THE OSCILLATION FUNCTION PROPERLY, SO ANOTHER CONSUMABLE HAD TO BE USED TO SOLVE THE PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 22803654 ↗
• MalfunctionMay 10, 2024Break; Break

  ON 04/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8400CTD TORPEDO BLADE BROKE WHILE RESECTING A SUTURE. AN AR-3636 DID NOT DEPLOY CORRECTLY SO IT NEEDED TO BE REMOVED AND THE SURGEON ELECTED TO USE THE TORPEDO TO REMOVE THE EXCESS SUTURE FROM THE JOINT. IT BROKE WHILE RESECTING THE SUTURE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 09/25/2024. WHERE THE SALES REPRESENTATIVE STATED THE AR-3636 WAS USED WHEN HARD BONE WAS ENCOUNTERED AND THE ANCHOR DID NOT FULLY SEAT. THE REPAIR SUTURE COULD NOT PASS THROUGH THE ANCHOR. ALL FRAGMENTS WERE NOT RETRIEVED FROM THE PATIENT, AND ANOTHER AR-3636 WAS USED TO PROCEED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286634 ↗
• MalfunctionApr 24, 2024Break; Break

  ON 04/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-8400CTD 4MM CURVED TORPEDO SHAVER WAS BROKEN. THE SHAFT OF THE SHAVER ATTACHMENT WAS BENT AND PIECES OF METAL WERE STICKING OUT OF THE SHAFT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175852 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT THE DEVICE DOESN`T WORK ANYMORE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE ASK 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. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692415 ↗
• MalfunctionApr 12, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE INSIDE THE PATIENT DURING A KNEE ARTHROSCOPY ALTHOUGH NO WAS FORCE APPLIED BY THE SURGEON AND NO LEVERING WAS APPLIED. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648346 ↗