MAUDE Adverse Event Report: ARTHREX, INC. AR-400UB UNSTERILE BATTERY; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	AR-400UB UNSTERILE BATTERY
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/28/2022, 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.Requested additional information.
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
Confirmed.The thermal event has caused significant damage to the pcb and it¿s components, root cause can¿t be determined.From the data it appears that the fuse may not have opened properly.This failure caused the pcba temperature to rise, centered on the fuse, due to the wattage driven through the heater element of the fuse to activate it.The temperature of the pcb at the fuse continued to increase until the temperature exceeded the pcb material 150°c tg, causing it to break down.With the fuse located above cell 3, cell 3 overheated.The vent on the cell opened once the temperature increased the internal cell pressure above its threshold.From the teardown of cell 3, the cell was not shorted and did not go into thermal runaway.Eventually, the pcb melted and shorted multiple conductors contributing to the pcb heating.

• Brand Name: AR-400UB UNSTERILE BATTERY
• 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: 13839510
• Report Number: 1220246-2022-04616
• Device Sequence Number: 5812794
• Product Code: HWE
• UDI-Device Identifier: 00888867223332
• UDI-Public: 00888867223332
• 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: AR-400UB UNSTERILE BATTERY
• Device Catalogue Number: AR-400UB
• Device Lot Number: GB6318581
• 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: 03/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown