MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, SMALL HUB, 3.5MM X 7 CM; BURR,SURGICAL

Model Number	POWERASP, SMALL HUB, 3.5MM X 7 CM
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handpiece became hot when used with an ar-9350pr and the ar-8305 console reported a critical error.The console was turned off then on again and the power rasp did not work.
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 user error of the device due to insufficient fluid flow during use.

• Brand Name: POWERASP, SMALL HUB, 3.5MM X 7 CM
• 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: emily shafer ; 8009337001
• MDR Report Key: 19534165
• Report Number: 1220246-2024-05756
• Device Sequence Number: 8412358
• Product Code: GFF
• UDI-Device Identifier: 00888867251953
• UDI-Public: 00888867251953
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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
• Report Date (Section B): 06/13/2024

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: POWERASP, SMALL HUB, 3.5MM X 7 CM
• Device Catalogue Number: AR-9350PR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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