MAUDE Adverse Event Report: ARTHREX, INC. POWERPICK, 30 DEG; BURR,SURGICAL

Model Number	POWERPICK, 30 DEG
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
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.Complaint confirmed.One unpackaged ar-8150pp-30 (no batch information provided) was received for investigation.Visual inspection identified signs of use across the cutting tip (superficial surface damage).Upon initial deployment, the cutting tip did not completely clear the outer tube.The device was disassembled, and upon reassembly, the tip was able to be deployed further.The cause remains undetermined.
Event or Problem Description
It was reported that upon opening the ar-8150pp-30 power pick to the field, it was being checked to make sure the lever to deploy the pick part of the instrument worked, but when the lever was activated the pick did not deploy completely.A second pick from the same box was opened and used to complete the procedure.

• Brand Name: POWERPICK, 30 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: 19243305
• Report Number: 1220246-2024-02780
• Device Sequence Number: 7495606
• Product Code: GFA
• UDI-Device Identifier: 00888867042902
• UDI-Public: 00888867042902
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: POWERPICK, 30 DEG
• Device Catalogue Number: AR-8150PP-30
• Device Lot Number: 10673720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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