Arthrex® AR-2386-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867344679), received between Jul 6, 2023 and Dec 10, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Failure to Cut; Failure to Cut

  ON 11/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2386-10 QUADPRO HARVESTER WAS UNABLE TO CUT THE QUAD GRAFT OUT OF THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770082 ↗
• MalfunctionJul 17, 2025Sharp Edges; Sharp Edges

  ON 06/23/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2386-10 QUADPRO HARVESTER WAS ROUGH AROUND ONE PORTION OF THE TIP OF THE DEVICE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532409 ↗
• MalfunctionFeb 3, 2025Dull, Blunt; Dull, Blunt

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2386-10 QUADPRO¿ HARVESTER, 10 MM, WAS TOO DULL AND WOULD NOT CUT TENDON DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/14/2025: THIS WAS DISCOVERED DURING AN ACL AUTO QUAD PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING A DIFFERENT QUAD PRO HARVESTER. THE CASE WAS DELAYED 5 MINUTES. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21296695 ↗
• InjurySep 5, 2024Dull, Blunt; Dull, Blunt

  ON 8/9/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2386-10 QUADPRO HARVESTER WAS UNABLE TO CUT THE TENDON. ALTHOUGH IT WAS APPROPRIATE TO HARVEST THE RECTUS FEMORIS MUSCLE, IT WAS NOT POSSIBLE TO CUT IT, SO THE TENDON WAS HARVESTED BY MAKING A LARGE INCISION IN THE SKIN AND CUTTING IT WITH A SCALPEL. THIS WAS DISCOVERED DURING A CASE AND AN ADDITIONAL INCISION HAD TO BE MADE IN ORDER TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20146048 ↗
• MalfunctionJun 7, 2024Dull, Blunt; Dull, Blunt

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2386-10 QUADPRO¿ HARVESTER IS DULL. THIS OCCURRED DURING A CASE, THE HARVESTER WAS TO DULL TO CUT THE SUTURES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19486629 ↗
• MalfunctionJun 6, 2024Material Deformation; Material Deformation

  ON 10/3/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2386-10 QUADPRO THINNED OUT THE GRAFT OUT PROXIMALLY. WHAT STARTED AS A 10MM GRAFT, ENDED WITH AN 8MM ON THE PROXIMAL END. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19478268 ↗
• MalfunctionJun 5, 2024Dull, Blunt; Dull, Blunt

  ON 06/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-2386-10 HARVESTER WOULD NOT CUT THE GRAFT. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469287 ↗
• MalfunctionMay 22, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED ON 07/19/2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2386-10 QUAD PRO HARVESTER WAS DULL AND WOULD NOT CUT GRAFT. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371351 ↗
• MalfunctionJan 2, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED ON 12/21/2023: THIS WAS DISCOVERED DURING A QUAD ACL PROCEDURE ON (B)(6), WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM. NOTHING BROKE INSIDE THE PATIENT AND THERE WAS NO REPORTED CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18431406 ↗
• MalfunctionOct 12, 2023Dull, Blunt; Dull, Blunt

  ON 09/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2386-10 QUADPRO¿ HARVESTER WOULD NOT CUT THE TENDON. THIS OCCURRED DURING A CASE WHERE A REUSABLE QUAD CUTTER WAS USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923128 ↗
• MalfunctionOct 10, 2023Failure to Cut; Failure to Cut

  ON 09/12/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2386-10 QUADPRO¿ HARVESTER WAS NOT CUTTING THE GRAFT. THIS OCCURRED DURING A QUAD ACL ON (B)(6) 2023 THEY WERE ABLE TO HARVEST THE GRAFT FINE BUT WHEN THEY WENT FOR THE FINAL CUT THEY COULDN¿T GET IT. AFTER ATTEMPTING TO MALLET THE BLACK OBTURATOR DOWN AND PUTTING SALINE DOWN THE HARVESTER TO LUBRICATE IT NEITHER WORKED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17908410 ↗
• MalfunctionJul 26, 2023Dull, Blunt; Dull, Blunt

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2386-10 HARVESTER IS DULL. THIS WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION, WHEN THEY BEGAN HARVESTING THE DEVICE WAS TOO DULL AND COULD NOT HARVEST THE GRAFT. ANOTHER AR-2386-10 WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398941 ↗
• MalfunctionJul 6, 2023Failure to Advance; Failure to Advance

  ON 6/9/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON TRIED TO CUT A GRAFT WITH AR-2386-10 QUADPRO HARVESTER AND PLUNGER. THE PLUNGER WOULD NOT ADVANCE DESPITE MULTIPLE ATTEMPTS. THE PLUNGER WAS REMOVED AND THE SURGEON TRIED AGAIN TO CUT BUT, WITH NO SUCCESS. A NEW QUADPRO WAS OPENED AND A PLUNGER FROM NEW QUADPRO WAS INSERTED. GRAFT WAS CUT SUCCESSFULLY WITH NO EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17272435 ↗