Arthrex® AR-2384Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867098244), received between Jun 9, 2017 and Aug 17, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277344 ↗
• MalfunctionMar 6, 2026Dull, Blunt

  ON 13-FEB-2026, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-2384 QUAD TENDON STRIPPER-CUTTER WAS NOT WORKING PROPERLY. THE SURGEON HAD A REALLY DIFFICULT TIME CUTTING THE GRAFT, THE DEVICE ALMOST FELT STICKY AND THAT THE SQUEEZE HANDLE MECHANISM WAS OFF. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531403 ↗
• MalfunctionMar 5, 2026Use of Device Problem

  ON 11-FEB-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-2384 QUAD TENDON STRIPPER-CUTTERS DID NOT WORK UPON THE SECOND USE OF THE DEVICE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518330 ↗
• MalfunctionMar 5, 2026Use of Device Problem

  ON 11-FEB-2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT A QTY. 2 OF AR-2384 QUAD TENDON STRIPPER-CUTTERS DID NOT WORK UPON THE SECOND USE OF THE DEVICE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518248 ↗
• MalfunctionDec 29, 2025Dull, Blunt; Dull, Blunt

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-2384, QUAD TENDON STRIPPER-CUTTER, WAS BLUNT. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE CUTTER STILL WORKED BUT WAS BLUNT AND WAS HARD TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906608 ↗
• MalfunctionJan 2, 2025Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE, VIA (B)(4), REPORTED THAT AN AR-2384 QUAD TENDON-STRIPPER CUTTER BROKE DURING A CASE. THIS DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060389 ↗
• MalfunctionOct 25, 2024Dull, Blunt; Dull, Blunt

  ON 10/15/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-2384 QUAD TENDON STRIPPER-CUTTER BLADE WAS NOT WORKING; IT WAS NOT CUTTING PROPERLY. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535237 ↗
• MalfunctionOct 25, 2024Dull, Blunt; Dull, Blunt

  ON 10/15/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (QTY. (B)(4) OF AN AR-2384 QUAD TENDON STRIPPER-CUTTER BLADE WAS NOT WORKING; IT WAS NOT CUTTING PROPERLY. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534186 ↗
• MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt

  ON 07/17/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-2384 QUAD TENDON STRIPPER CUTTER WAS NOT SHARP ENOUGH. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918191 ↗
• MalfunctionJun 14, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE DEVICE IS DULL. 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 19536268 ↗
• MalfunctionJun 7, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 03/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2384 STRIPPER-CUTTERS PRONGS ARE BENT. THIS OCCURRED DURING A QUAD TENDON HARVEST, A NEW AR-2384 WAS USED TO COMPLETED THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491259 ↗
• MalfunctionJun 5, 2024Dull, Blunt; Dull, Blunt

  ON 03/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-2384 CUTTER IS DULL. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468513 ↗
• MalfunctionJun 1, 2024Failure to Cut; Failure to Cut

  ON 02/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-2384 QUAD TENDON STRIPPER-CUTTERS BLADE IS DULL, IT IS NOT STRIPPING. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442068 ↗
• MalfunctionMay 14, 2024Overfill; Overfill

  ON 06/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-2384 TENDON STRIPPER-CUTTER BLADES ON THE CUTTING PORTION HAVE BEEN DIFFICULT FOR THE SURGEON TO CUT THE TENDON OUT, DOESN'T SEEM SHARP. THIS OCCURRED IN AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310845 ↗
• MalfunctionApr 24, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE AR-2384 QUAD TENDON CUTTER IS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171009 ↗
• MalfunctionMar 22, 2024Failure to Cut; Failure to Cut

  ON 3/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2384 QUAD TENDON STRIPPER-CUTTER BLADE WAS NOT CUTTING THE TENDON AND SEEMED TO BE LOOSE WITHIN THE MECHANISM. THE CASE WAS COMPLETED BY RETURNING TO USING AN 11-BLADE WITH NO ADVERSE EFFECT ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960584 ↗
• MalfunctionMar 18, 2024Dull, Blunt; Dull, Blunt

  ON 02/26/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2384 QUAD TENDON STRIPPER COULD NOT CUT THE TISSUE DURING A QUAD TENDON GRAFT HARVEST BECAUSE IT WAS DULL. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921561 ↗
• MalfunctionMar 4, 2024Dull, Blunt; Dull, Blunt

  ON 02/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2384 QUAD TENDON CUTTER IS DULL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825261 ↗
• MalfunctionFeb 9, 2024Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 01/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2384 TENDON STRIPPER IS NOT LOCKING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676646 ↗
• MalfunctionNov 16, 2023Use of Device Problem; Use of Device Problem

  ON 24TH OCTOBER 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2384, QUAD TENDON STRIPPER-CUTTER, HAD DIFFICULTIES OPENING ALL THE WAY AND WAS VERY STIFF. IT WAS ABLE TO BE PRIED OPEN BY FORCING THE HANDGRIP, HOWEVER IT WAS DEEMED INAPPROPRIATE TO CONTINUE TO USE THE PRODUCT. THIS WAS DISCOVERED WHEN THE CONSIGNED INSTRUMENTATION WAS OPENED DURING A REGULAR QUADRICEPS ACL PROCEDURE ON (B)(6). THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 18150816 ↗
• MalfunctionNov 9, 2023Failure to Cut; Failure to Cut

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06062844 THAT AN AR-2384 QUAD TENDON STRIPPER-CUTTER DID NOT CUT THE TENDON AT ALL AND WAS THE FIRST TIME IT WAS USED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104285 ↗
• MalfunctionAug 31, 2023Dull, Blunt; Dull, Blunt

  ON 8/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2384 QUAD TENDON STRIPPER-CUTTER, PART OF SET AR-2382S WITH LOT NUMBER 15100379, HAD AN ISSUE. DURING THE CASE, THE SURGEON NOTICED THAT THE BLADES ON THE QUAD TENDON STRIPPER-CUTTER WERE DULL. NO PATIENT AFFECT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662127 ↗
• MalfunctionJul 17, 2023Dull, Blunt; Dull, Blunt

  ON 06/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2384 QUAD TENDON CUTTER IS DULL AND HAD TROUBLE CUTTING TENDON. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335279 ↗
• InjuryJun 9, 2017Detachment Of Device Component; Failure to Cut

  IT WAS REPORTED THAT DURING AN ACL CASE, THE SURGEON TRIED TO CUT THE QUAD TENDON MULTIPLE TIMES WITH THE AR-2384, QUAD TENDON STRIPPER-CUTTER. THE SURGEON EXTENDED THE INCISION AND USED SCISSORS TO CUT THE TENDON. WHEN THE CASE WAS COMPLETED THE SALES REP INSPECTED THE DEVICE AND FOUND THE WELD WHERE THE SHAFT MEETS THE HANDLE WAS NOT INTACT.

  Patient problems: No Code Available

  MAUDE report 6629190 ↗