MAUDE Adverse Event Report: ARTHREX, INC. POWERASP, 3.5MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	POWERASP, 3.5MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an ankle-arthroscopy, the movement of the rasp became sluggish and the inner cylinder came off during direct patient interaction.The procedure was completed using a new product.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the inner cylinder had fractured off from the hub of the device.Due to the disassembled state of the device, functional testing could not be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: POWERASP, 3.5MM X 13CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12393498
• Report Number: 1220246-2021-03589
• Device Sequence Number: 4181492
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1