Arthrex® AR-8704Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867044760), received between Jan 26, 2024 and May 21, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2/28/2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8704 SUTURELASSO LOOP WAS ALREADY TORN WHEN THE SURGEON TRIED TO USE IT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360225 ↗
• MalfunctionMay 13, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE WIRE DOES NOT PASS THROUGH THE PIN CORRECTLY AND MAY EVEN GET BLOCKED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299117 ↗
• MalfunctionMay 9, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANKLE LIGAMENTOPLASTY SURGERY THE WIRE OF THE DEVICE DID NOT RUN. NO PART OF THE DEVICE BROKE OFF. 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 19277664 ↗
• MalfunctionFeb 15, 2024Failure to Advance; Failure to Advance

  ON 01/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT THE LASSO LOOP WITHIN AN AR-8704 MICRO SUTRLASSO,TFCC,SHT,70°BEND WAS UNABLE TO ADVANCE DURING A ARTHROBROSTROM SURGERY PERFORMED BY DR. ANANDAKUMAR. THE CASE WAS RESOLVED BY USING A 14G CANNULA AS A REPLACEMENT TO AR-8704. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714351 ↗
• MalfunctionJan 26, 2024Positioning Failure; Defective Device; Positioning Failure; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY THE WIRE DID NOT RISE IN THE TROCAR. 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 18587114 ↗