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

Model Number	ARTHREX AR-600,HANDPIECE
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
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.The reported event was not confirmed.The supplier evaluation revealed a loose coupler and a chipped coating at the stator winding but there was no issue found with the motor or power of the device.
Event or Problem Description
It was reported that during surgeries over an extended period of time experienced lack of power in the machine.This was especially noticed during total knee replacement procedures where a lot of sawing power is needed.It was further reported that the blade got stuck in the bone due to this failure and the surgeon had to apply much force to be able to saw and it still went very slowly.The customer has replaced the attachment chuck to resolve the reported issue without success.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 19372217
• Report Number: 1220246-2024-03653
• Device Sequence Number: 15358188
• Product Code: HWE
• UDI-Device Identifier: 00888867110175
• UDI-Public: 00888867110175
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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
• Device Lot Number: 13660652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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