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

Model Number	QUADPRO¿ HARVESTER, 9 MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Due to the device not being returned, we are unable to confirm the reported event.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue.

• 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: 19144853
• Report Number: 1220246-2024-02173
• Device Sequence Number: 7406253
• Product Code: LXH
• UDI-Device Identifier: 00888867344662
• UDI-Public: 00888867344662
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 22F67
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown