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	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a facility representative via (b)(4) that an ar-6482 dw remote has exposed wires.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint confirmed.Device damaged due to customer use and wear and tear.This device is obsolete.See attached memo in complaint file.

• 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: 22493913
• Report Number: 1220246-2025-02844
• Device Sequence Number: 7905033
• Product Code: HRX
• UDI-Device Identifier: 00888867039421
• UDI-Public: (01)00888867039421(11)230803(10)15124201
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K083707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 15124201
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown