Arthrex® AR-2386-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867344662), received between Feb 6, 2023 and May 20, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 5/20/2025: AN AUTOGRAFT QUAD TENDON ACL RECONSTRUCTION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED DUE TO IDENTIFIED ISSUES. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED BEYOND THE EXPECTED DURATION, WITH THE PATIENT REMAINING UNDER FOR AN ADDITIONAL 10 MINUTES. NO SURGICAL INSTRUMENTS OR IMPLANTS BROKE, AND NO FRAGMENTS WERE ENCOUNTERED DURING THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052517 ↗
• MalfunctionMay 19, 2025Failure to Cut; Physical Resistance/Sticking; Failure to Cut; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SURGEON WAS NOT ABLE TO AMPUTATE THE GRAFT USING THE QUADPRO DEVICE AR-2386-09 (LOT: 23F22). THE TIP OF THE STRIPPER WAS BLOCKING IN THE TRANSPARENT TUBE AND WAS NOT AMPUTATING THE QUAD TENDON. THE SURGEON HAD TO FORCE THE DEVICE AND CUT THE SMALLER LENGTH THEN NEEDED. HE HAD TO CHANGE THE SURGICAL TECHNIQUE AND HARVESTED THE HAMSTRING TENDONS INSTEAD. TWO TENDONS WAS HARVESTED ON THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-10300F). IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043894 ↗
• MalfunctionApr 22, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2386-09 QUADPRO¿ HARVESTER MALFUNCTIONED DURING A CASE ON (B)(6) 2025. THERE WAS NO IMPACT ON THE PATIENT OR CASE AS THEY HAD TWO HARVESTERS PRESENT FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883994 ↗
• MalfunctionFeb 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2386-09 QUADPRO¿ HARVESTER DID NOT FULLY AMPUTATE THE GRAFT. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025 WHEN THE 9MM QUADPRO HARVESTER DID NOT FULLY AMPUTATE THE GRAFT. THE PUSH ROD BECAME STUCK INSIDE THE HARVESTER AND HAD TO BE FORCED APART USING A MALLET AND OSTEOTOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392181 ↗
• MalfunctionApr 25, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT (2) AR-2386-09 QUADPRO¿ HARVESTERS WERE NOT WORKING. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188317 ↗
• MalfunctionApr 25, 2024Defective Device; Defective Device

  ON 04/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-2386-09 QUADPRO¿ HARVESTERS WERE NOT WORKING. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185263 ↗
• MalfunctionApr 19, 2024Defective Device; Defective Device

  ON (B)6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-2386-09 QUADPRO¿ HARVESTER WOULD NOT HARVEST THE TENDON. THE DEVICE WAS BRAND NEW AND OUT OF THE BOX. THIS OCCURRED DURING A CASE WHERE ANOTHER DEVICE WAS OPENED, AND THE SAME OUTCOME. THE PATIENT WAS IN THE ROOM, BUT NO ADVERSE EVENT. NOTHING BROKE, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144853 ↗
• MalfunctionApr 18, 2024Dull, Blunt; Dull, Blunt

  ON 03/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT QTY. 2 OF AN AR-2386-09 QUADPRO HARVESTER, 9 MM WOULD NOT HARVEST THE TENDON, BRAND NEW OUT OF BOX. THE SALES REPRESENTATIVE STATED THAT THEY TRIED THE SAME PART AND LOT NUMBER WITH THE SAME OUTCOME. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139371 ↗
• MalfunctionApr 17, 2024Dull, Blunt; Dull, Blunt

  ON 03/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT QTY. 2 OF AN AR-2386-09 QUADPRO HARVESTER, 9 MM WOULD NOT HARVEST THE TENDON, BRAND NEW OUT OF BOX. THE SALES REPRESENTATIVE STATED THAT THEY TRIED THE SAME PART AND LOT NUMBER WITH THE SAME OUTCOME. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126705 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE TIP, STUB AND HANDLE OF THE DEVICE BROKE OFF WHILE SCREWING IN. 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. NO FURTHER INFORMATION WAS PROVIDED. (B)(6) 2023. IT WAS REPORTED THAT DURING A KNEE SURGERY, THE HANDLE OF THE DEVICE BROKE OFF WHILE SCREWING IN. THE SURGEON STATED THAT THIS MIGHT HAVE BEEN RELATED TO THE BLUNT TIP. 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17995550 ↗
• MalfunctionJul 24, 2023Loose or Intermittent Connection; Material Separation; Loose or Intermittent Connection; Material Separation

  ON 6/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2386-09 QUAD PRO HARVESTER HAD AN ISSUE DURING AN ACL PROCEDURE ON (B)(6) 2023. THE QUAD HARVESTER TIP SEEMED LOOSE ON THE HARVESTING DEVICE. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THE DEVICE WAS DISCARDED BY THE FACILITY. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. ON 7/6/2023, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION OVER THE PHONE: THIS OCCURRED DURING THE USE OF THE DEVICE. WHEN THE SURGEON INSERTED THE QUAD PRO HARVESTER, THE METAL CUTTING BLADE WAS ROCKING/WIGGLING WITHIN THE PLASTIC CANNULA. THE DEVICE WAS REMOVED IN ONE PIECE FROM THE PATIENT, NOTHING BROKE OFF. A SECOND DEVICE WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE CASE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380086 ↗
• InjuryFeb 6, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2386-09 QUAD PRO HARVESTER WAS MISUSED BY THE SURGEON. SURGEON PREMATURELY SEVERED TENDON. WAS DOING BONE BLOCK TECHNIQUE. LIKELY POINTING TO ANTERIOR. PATIENT BONE BLOCK AND TRUNCATED TENDON WAS STITCHED BACK INTO PATIENT KNEE AND SURGEON CONVERTED TO HAMSTRING TENDON HARVEST. CASE INVOLVEMENT, NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON (B)(6) 2022, RESPONSE (B)(6) 2022. PATIENT WAS NOT KEPT UNDER ADDITIONAL ANESTHESIA TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16303264 ↗