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

Model Number	QUADPRO¿ HARVESTER, 9 MM
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
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 6/27/2023, it was reported by a sales representative via sems that an ar-2386-09 quad pro harvester had an issue during an acl procedure on (b)(6) 2023.The quad harvester tip seemed loose on the harvesting device.A second device was opened to complete the case.The device was discarded by the facility.This occurred during use with no patient harm.Additional information was requested.On 7/6/2023, the sales representative stated the following information over the phone: this occurred during the use of the device.When the surgeon inserted the quad pro harvester, the metal cutting blade was rocking/wiggling within the plastic cannula.The device was removed in one piece from the patient, nothing broke off.A second device with an unknown lot number was used to complete the case successfully.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image received from the field, the quadpro¿ harvester appears to be damaged on the distal end.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17380086
• Report Number: 1220246-2023-07294
• Device Sequence Number: 6073015
• Product Code: LXH
• UDI-Device Identifier: 00888867344662
• UDI-Public: 00888867344662
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/10/2025

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 Expiration Date: 09/30/2026
• Device Model Number: QUADPRO¿ HARVESTER, 9 MM
• Device Catalogue Number: AR-2386-09
• Device Lot Number: 21N07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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