MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, 3.5MM X 13CM; ARTHROSCOPIC ACCESSORIES

Model Number	POWERASP, 3.5MM X 13CM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/1/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8350pr powerasp would not resize to a 4mm degree.Another device was used to complete the case.After the procedure, the device was examined, and it was determined the inner tube could not move up or down.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-8350pr, serial/batch number (b)(6), powerasp, was received for investigation.Visual evaluation under a magnifier noted striation marks along the shaft.The inner tube had debris lodged inside as well.Functional testing was not performed due to the damage of the device: the inner tube was immobile.Dfu-0215-7; precautions 8-11: excessive ¿loading¿ on the powerasp device will disengage the cam mechanism and stall the cutting effectiveness.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.11.All arthrex disposable arthroscopic devices are preassembled, packaged sterile, and ready for use.Irreversible damage will result from any attempt to disassemble curved blades, flushcut burrs, clearcut burrs, powerpick, and powerasp devices.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: POWERASP, 3.5MM X 13CM
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 18905731
• Report Number: 1220246-2024-01479
• Device Sequence Number: 7919485
• Product Code: GFF
• UDI-Device Identifier: 00888867043312
• UDI-Public: 00888867043312
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/03/2024

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: POWERASP, 3.5MM X 13CM
• Device Catalogue Number: AR-8350PR
• Device Lot Number: 15131072
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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