Arthrex® AR-2385-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867098251), received between Jun 6, 2024 and Mar 26, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT 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 24699599 ↗
• MalfunctionMar 26, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT 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 24699595 ↗
• MalfunctionMar 26, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT 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 24699588 ↗
• MalfunctionMar 26, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT 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 24698774 ↗
• MalfunctionMar 26, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY IT WAS FOUND THAT THE BLADE IS DULL AND DOES NOT CUT INTO THE TENDON. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE A DIFFERENT 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 24698705 ↗
• MalfunctionJun 14, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 08/02/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-2385-09 9MM TENDON STRIPPER BLADE IS BENT. THIS WAS DISCOVERED WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537571 ↗
• MalfunctionJun 6, 2024Dull, Blunt; Dull, Blunt

  ON 05/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-2385-09 TENDON STRIPPER BLADE IS DULL. THIS WAS DISCOVERED ON 05/04/2022 DURING A QUAD ACL WHEN ATTEMPTING TO HARVEST THE GRAFT THE STRIPPER BLADE WAS TOO DULL TO CUT. THE CASE WAS COMPLETED BY FREE HAND RATHER THAN OPENING ANOTHER BLADE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481420 ↗