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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/14/2024, it was reported by a distributor via (b)(4) that an ar-8150px-45 power picks tip broke.This occurred during a case, where another powerpick was used to proceed with the case.
Event or Problem Description
On 10/18/2024 additional information was received from a distributor via email who stated that the procedure was a knee arthroscopy.All fragments were removed from the patient.No pictures were taken.A new product was opened and completed the procedure.No delays or need for additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6, based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.

• 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: 20557874
• Report Number: 1220246-2024-08304
• Device Sequence Number: 8866104
• Product Code: GFF
• UDI-Device Identifier: 00888867042926
• UDI-Public: (01)00888867042926(11)240510(17)290430(10)15246723
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Followup
• Report Date (Section B): 08/20/2025

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 Model Number: POWERPICK, 45 DEG
• Device Catalogue Number: AR-8150PX-45
• Device Lot Number: 15246723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 10/18/2024; 08/19/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/19/2024; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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