MAUDE Adverse Event Report: ARTHREX, INC. CHARGING STATION AR-300/AR-600 BATTERIES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	CHARGING STATION AR-300/AR-600 BATTERIES
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2021
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 the device smells burned and the charging led is defective.There was no harm for patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation showed minor scratches around the device.When opening the device for evaluation, it was noticed that the connectors to the board of the power switch are discolored.Device functioning test was not performed as the complaint allegation has a potential fire hazard.

• Brand Name: CHARGING STATION AR-300/AR-600 BATTERIES
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12122959
• Report Number: 1220246-2021-03354
• Device Sequence Number: 14350132
• Product Code: HWE
• UDI-Device Identifier: 00888867099364
• UDI-Public: 00888867099364
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/20/2021

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: CHARGING STATION AR-300/AR-600 BATTERIES
• Device Catalogue Number: AR-300/600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/20/2021
• Patient Sequence Number: 1