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

Device Problems Device Emits Odor (1425); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 262513423
• Report Number: 1220246-2021-03354
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867099364
• UDI-Public: 00888867099364
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 08/20/2021
• Patient Sequence Number: 1