MAUDE Adverse Event Report: ARTHREX, INC. QUADPRO¿ HARVESTER, 10 MM; PASSER

Model Number	QUADPRO¿ HARVESTER, 10 MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that an ar-2386-10 quadpro¿ harvester, 10 mm, was too dull and would not cut tendon during the case.The patient was not affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 01/14/2025: this was discovered during an acl auto quad procedure on (b)(6) 2025.The case was completed using a different quad pro harvester.The case was delayed 5 minutes.There was no additional anesthesia administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon use.

• Brand Name: QUADPRO¿ HARVESTER, 10 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: 21296695
• Report Number: 1220246-2025-00145
• Device Sequence Number: 9208155
• Product Code: LXH
• UDI-Device Identifier: 00888867344679
• UDI-Public: (01)00888867344679(11)230701(17)280630(10)23J05
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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, 10 MM
• Device Catalogue Number: AR-2386-10
• Device Lot Number: 23J05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown