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

Model Number	POWERPICK, 45 DEG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, an arthrex employee reported via email that powerpick ar-8150px-45 (lot/serial (b)(6) fractured internally at the spring mechanism after drilling several holes during a hip arthroscopy procedure on (b)(6) 2026.According to dr.Ben ang, no arthrex representative was present during the case.The surgeon described operating at a high forward speed (above 7000 rpm) and initiating drilling before the tip made contact with the bone, maintaining continuous drilling until exiting the bone.His hand position remained steady without movement throughout the process.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24132273
• Report Number: 1220246-2026-00268
• Device Sequence Number: 10387174
• Product Code: GFF
• UDI-Device Identifier: 00888867042926
• UDI-Public: (01)00888867042926(11)250407(17)300331(10)15416680
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/26/2026

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, 45 DEG
• Device Catalogue Number: AR-8150PX-45
• Device Lot Number: 15416680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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