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

Model Number	QUADPRO¿ HARVESTER, 9 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2023
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
It was reported that during a knee surgery, the tip, stub and handle of the device broke off while screwing in.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information was provided.(b)(6) 2023.It was reported that during a knee surgery, the handle of the device broke off while screwing in.The surgeon stated that this might have been related to the blunt tip.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information was provided.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint was confirmed.One unpacked ar-2386-09 serial/batch number (b)(6) was received for investigation.Visual inspection found that the cutter cap was detached from the cutter rod.It was also noted that one of the legs of the black plastic was broken off.No functional testing was performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces used when turning the harvester.

• 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: 17995550
• Report Number: 1220246-2023-08334
• Device Sequence Number: 6754096
• Product Code: LXH
• UDI-Device Identifier: 00888867344662
• UDI-Public: 00888867344662
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/14/2024

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: 22C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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