MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-300,HANDPIECE; POWERED SURG ORTHOPEDIC INSTR

Model Number	ARTHREX AR-300,HANDPIECE
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
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.Event description: it was reported that the locking screw loosens during oscillating sawing, so that the saw blade loosens under pressure load.The reported event was not confirmed.The supplier evaluation did not reveal that the locking screw loosens during oscillating sawing, so that the saw blade loosens under pressure load.However, the control electronics are defective and cracked.Further the ball bearings are rough.The condition of the device is consistent with normal wear and tear with use and handling.
Event or Problem Description
It was reported that the locking screw loosens during oscillating sawing, so that the saw blade loosens under pressure load.There was no harm for the patient, operator or third party reported.No further information received.

• Brand Name: ARTHREX AR-300,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: 19381390
• Report Number: 1220246-2024-03719
• Device Sequence Number: 20418483
• Product Code: HWE
• UDI-Device Identifier: 00888867099357
• UDI-Public: 00888867099357
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• 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: ARTHREX AR-300,HANDPIECE
• Device Catalogue Number: AR-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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