MAUDE Adverse Event Report: ARTHREX, INC. QUADPRO¿ HARVESTER, 9 MM; PASSER

Model Number	QUADPRO¿ HARVESTER, 9 MM
Medical Device Problem Codes	Failure to Cut (2587); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-2386-09 serial/batch 23f22 was received for evaluation.Functional testing revealed that the cutter rod and cutter cap were broken.When moving the cap, the cutter rod remain stationary, which made removal difficult.The stripper blade was tested using a mock tissue, and it was observed that it cut the tissue without any issues.A visual evaluation found tissue wrapped around the cutter rod, and the cap was separated from the cutter rod.The reported failure is most likely due to a user error, improper surgical technique.

• Brand Name: QUADPRO¿ HARVESTER, 9 MM
• Common Device Name: PASSER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22043894
• Report Number: 1220246-2025-02092
• Device Sequence Number: 15773065
• Product Code: LXH
• UDI-Device Identifier: 00888867344662
• UDI-Public: (01)00888867344662(11)230601(17)280531(10)23F22
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QUADPRO¿ HARVESTER, 9 MM
• Device Catalogue Number: AR-2386-09
• Device Lot Number: 23F22
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown