MAUDE Adverse Event Report: ARTHREX, INC. QUADPRO¿ HARVESTER, 11 MM; PASSER

Model Number	QUADPRO¿ HARVESTER, 11 MM
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/13/2025, it was reported by a sales representative via (b)(4) that an ar-2386-11 quadpro harvester plunger would not cut the graft.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-2386-11 quadpro¿ harvester, batch 21r08, was received for evaluation.Visual investigation noted nicked cutting edges and surface damage on the device.The most likely cause of the reported failure can be attributed to misuse/mishandling, such as: inadequate graft tensioning, misalignment of the harvester and plunger, or off-axis actuation leading to an incomplete cut.Additionally, this is a single-use device with a manufacturing date of december 2021.Therefore, a potential of misuse is that the device may have been re-used in the field beyond its intended single-use design.The complaint allegation is confirmed.See attached images for reference.

• Brand Name: QUADPRO¿ HARVESTER, 11 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: 23697251
• Report Number: 1220246-2025-05330
• Device Sequence Number: 10216030
• Product Code: LXH
• UDI-Device Identifier: 00888867344686
• UDI-Public: (01)00888867344686(11)211201(17)261130(10)21R08
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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, 11 MM
• Device Catalogue Number: AR-2386-11
• Device Lot Number: 21R08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown