MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 45 DEG; BURR,SURGICAL

Model Number	POWERPICK, 45 DEG
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse of the device due to damage to the device.
Event or Problem Description
On 08/16/2021, it was reported by a sales representative via sems that ar-8150px-45 powerpick tip is not exposed to make the micro-perforations.This was discovered during a knee arthroscopy on (b)(6) 2021.Additional information 8/18/2021 on 08/18/2021, it was reported by an arthrex representative via email that ar-8150px-45 powerpick was stuck inside the cannula.This was discovered during a knee arthroscopy on 08/11/2021.The case was completed by using the microfracturing instruments.

• Brand Name: POWERPICK, 45 DEG
• Common Device Name: BURR,SURGICAL
• 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: 19391895
• Report Number: 1220246-2024-03846
• Device Sequence Number: 12705688
• Product Code: GFF
• UDI-Device Identifier: 00888867042926
• UDI-Public: 00888867042926
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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 Expiration Date: 01/31/2026
• Device Model Number: POWERPICK, 45 DEG
• Device Catalogue Number: AR-8150PX-45
• Device Lot Number: 12650119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown