MAUDE Adverse Event Report: ARTHREX, INC. UNIV BATT CHRGR - 300 400 600 BATT; POWERED SURG ORTHOPEDIC INSTR

Model Number	UNIV BATT CHRGR - 300 400 600 BATT
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the charging process smoke was emitted from the device and there was a smell of burning.The device was not located in a surgery room.There was no harm for patient, operator or third party reported.No further information received.Update avoe 29-jun-2022 it was confirmed that a burning smell was noticed but no smoke was seen.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The reported event was confirmed.The service evaluation revealed defective electronic components.The most likely cause for the reported failure can be attributed to a supplier process issue, due to defective electronics.

• Brand Name: UNIV BATT CHRGR - 300 400 600 BATT
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19382721
• Report Number: 1220246-2024-03744
• Device Sequence Number: 12347958
• Product Code: HWE
• UDI-Device Identifier: 00888867246355
• UDI-Public: 00888867246355
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/23/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown