Arthrex® AR-2385-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867098268), received between Apr 24, 2024 and Jun 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 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.

• MalfunctionJun 19, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A QUAD TENDON ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE KNIFE (10MM, AR-2385-10) WILL NOT FIT ON THE QUAD HANDLE INSTRUMENT (AR-2383). WITH A LOT OF FORCE THE KNIFE WILL GO ON THE INSERTER AND ALSO TO GET IT OFF THE HANDLE IS NOT EASY. 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 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 19569923 ↗
• MalfunctionJun 3, 2024Fitting Problem; Fitting Problem

  ON 11/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-1588RTT ACL TIGHTROPE THE 1ST PASS WENT THROUGH THE GRAFT AND THE NEEDLE POPPED OFF, ALONG WITH A AR-2385-10 TENDON GRAFT CUTTING BLADE WOULD NOT SNAP INTO INTO THE HANDLE IT SNAPS INTO IT DID NOT FIT. THIS OCCURRED DURING A ACL RECONSTRUCTION ON (B)(6) 2022. NEW DEVICES WERE BROUGHT IN, AND THE CASE WAS COMPLETED WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454328 ↗
• MalfunctionMay 26, 2024Defective Device; Defective Device

  ON 09/27/2021 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-2385-10 BLADE IS DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398891 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ON 5/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2385-10 TENDON STRIPPER BLADES WILL NOT LOCK ONTO THE HANDLE. THIS HAPPENED WITH MULTIPLE BLADES AND MULTIPLE HANDLES DURING THE SAME CASE. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373280 ↗
• MalfunctionApr 24, 2024Connection Problem; Connection Problem

  IT WAS REPORTED DURING A QUAD AUTOGRAFT ACL PROCEDURE THE BLADE WOULD NOT CLICK INTO THE HANDLE. IT WAS REPLACED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172377 ↗