MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-600,HANDPIECE; POWERED SURG ORTHOPEDIC INSTR

Model Number	ARTHREX AR-600,HANDPIECE
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device gets hot.There was no harm for patient, operator or third party reported.No further information received.Further questions will be asked.***update 11-nov-2021 the customer reported additionally that the problem was noticed during the surgery.The performance was noticeably weaker and then stopped.The engine was extremely hot, even with cooling in the form of a wet towel.The machine was replaced during the surgery.The patient or other persons were not harmed, and apart from the saw there was no damage at all.The surgery was completed successfully.There was no need to switch to another surgical technique.No second surgery was necessary.There was no harm for patient, operator or third party reported.
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.It was reported that the device gets hot.This event is not confirmed.The manufacturers evaluation did not reveal any failure with this device which caused the reported event.However, the evaluation revealed that the stator winding is corroded, the control electronic has a crack at the grouting, the stator sleeve at the handle is loose and the magnet did come loose from the rotor.

• Brand Name: ARTHREX AR-600,HANDPIECE
• 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: 19559509
• Report Number: 1220246-2024-05955
• Device Sequence Number: 4734835
• Product Code: HWE
• UDI-Device Identifier: 00888867110175
• UDI-Public: 00888867110175
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: ARTHREX AR-600,HANDPIECE
• Device Catalogue Number: AR-600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown