MAUDE Adverse Event Report: ARTHREX, INC. POWERASP,4.0MM X 13CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	POWERASP,4.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2021
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 scr procedure performed on an (b)(6) year-old female, the powerasp was unable to cut bone from the start of the surgery.The swivelock fell off and the inserter shaft was loose and not fixed; the issue did not resolve when it was returned to the base of the inserter.The procedure was completed using a new product with no patient harm reported.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400pr was received for investigation.Visual inspection identified internal damage to the outer hub.The retaining ring appeared chipped, as if attempts were made to open the internals of the hub through removing the retaining ring.Functional testing with an ar-8305 console and an ar-8330h handpiece revealed that the ar-8400pr was responsive in all modes, but rotated off-axis.Further visual inspection confirmed that the cam spring was not present, accounting for improper functionality observed.Due to the returned condition of the device, it cannot be confirmed that the spring was missing due to a manufacturing defect.The cause remains undetermined, although a probable cause can be attributed to mishandling.

• Brand Name: POWERASP,4.0MM 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: 12393511
• Report Number: 1220246-2021-03590
• Device Sequence Number: 19879107
• Product Code: GFF
• UDI-Device Identifier: 00888867043619
• UDI-Public: 00888867043619
• 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): 10/18/2021

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 Expiration Date: 04/30/2026
• Device Model Number: POWERASP,4.0MM X 13CM
• Device Catalogue Number: AR-8400PR
• Device Lot Number: 13248048
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1