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	Insufficient Information (4580)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 8/9/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2386-10 quadpro harvester was unable to cut the tendon.Although it was appropriate to harvest the rectus femoris muscle, it was not possible to cut it, so the tendon was harvested by making a large incision in the skin and cutting it with a scalpel.This was discovered during a case and an additional incision had to be made in order to complete the procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-2386-10 / batch 23e05 was received for investigation.Upon visual evaluation, it was noted that the outer tubing was cracked.Additionally, upon inspecting the device with a magnifier, it was noted that the inside tube had grind marks along it.Metal shavings were seen as well.The cutting tip also had significant nick marks along it, which is likely related to the complaint allegation.Functional test with a mock tendon, noted that the device cut through it.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device, and/ or not using the proper surgical technique.

• 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: 20146048
• Report Number: 1220246-2024-07378
• Device Sequence Number: 8397408
• Product Code: LXH
• UDI-Device Identifier: 00888867344679
• UDI-Public: 00888867344679
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QUADPRO¿ HARVESTER, 10 MM
• Device Catalogue Number: AR-2386-10
• Device Lot Number: 23E05
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown