MAUDE Adverse Event Report: ARTHREX, INC. MOTOR WITH CABLE 3.5M; POWERED SURG ORTHOPEDIC INSTR

Model Number	MOTOR WITH CABLE 3.5M
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/06/2022, it was reported by a sales representative via (b)(4) that on (b)(6) 2022 during an unknown procedure a ar-300b burr attachment would not capture the burr or spin when hitting foot pedal.Also a ar-200m motor got extremely hot, rags dunked in saline had to be used to hold the overheating handpiece to not burn the surgeons hand.There was no additional information provided.Additional information requested.
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause of the reported failure is wear and tear.

• Brand Name: MOTOR WITH CABLE 3.5M
• 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: 19387533
• Report Number: 1220246-2024-03777
• Device Sequence Number: 6913559
• Product Code: HWE
• UDI-Device Identifier: 00888867200708
• UDI-Public: 00888867200708
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Distributor
• 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: MOTOR WITH CABLE 3.5M
• Device Catalogue Number: AR-200M
• Device Lot Number: 12547718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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