MAUDE Adverse Event Report: ARTHREX, INC. DW REMOTE; ARTHROSCOPE AND ACCESSORIES

Model Number	DW REMOTE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/11/2024, it was reported by a sales representative via (b)(4) that an ar-6482 dw remote cord had exposed wires.The case was completed with another ar-6482 dw remote with no issues.This was discovered during a procedure, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The attached complaint handling memo for ar-6482 has been reviewed.No harms were associated with this event, and the ar-6482 device has become obsolete.Therefore, no further investigation is required.

• Brand Name: DW REMOTE
• Common Device Name: ARTHROSCOPE AND ACCESSORIES
• 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: 19683874
• Report Number: 1220246-2024-06606
• Device Sequence Number: 3211643
• Product Code: HRX
• UDI-Device Identifier: 00888867039421
• UDI-Public: 00888867039421
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: DW REMOTE
• Device Catalogue Number: AR-6482
• Device Lot Number: 10239646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown