MAUDE Adverse Event Report: ARTHREX, INC. UNIV BATT CHRGR - 300 400 600 BATT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	UNIV BATT CHRGR - 300 400 600 BATT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-400ubc battery charger and ar-400ub battery caught on fire and melted the console.
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.
Additional Manufacturer Narrative
No problem found.The charger was returned due to it was part of a thermal event.According to the investigation, the charger is fully functional and had no damage only a few marks from the thermal event.

• Brand Name: UNIV BATT CHRGR - 300 400 600 BATT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13839551
• Report Number: 1220246-2022-04619
• Device Sequence Number: 5812795
• Product Code: HWE
• UDI-Device Identifier: 00888867246355
• UDI-Public: 00888867246355
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: UNIV BATT CHRGR - 300 400 600 BATT
• Device Catalogue Number: AR-400UBC
• Device Lot Number: GB6373058
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown