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

Model Number	DW REMOTE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/06/2024, it was reported by a facility representative via sems-06478064 that an ar-6482 dualwave remotes wires were showing at the top.This was discovered during a procedure where they put a coban over it and kept it away from liquids.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has not yet been evaluated.The root cause of the event could not be determined from the information available and without device evaluation.When the device evaluation becomes available, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint was confirmed.One unpackaged ar-6482 serial number: 656325 was received.Upon visual investigation, it was noted that the cable was frayed at the base where it connects to the remote.Functional testing could not be performed due to damage to the device.A most likely cause can be attributed to misuse/mishandling due to damage to the device.Refer to investigation photos.

• 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: 18771333
• Report Number: 1220246-2024-01103
• Device Sequence Number: 4499739
• Product Code: HRX
• UDI-Device Identifier: 00888867039421
• UDI-Public: 00888867039421
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/22/2024

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: DW REMOTE
• Device Catalogue Number: AR-6482
• Device Lot Number: 14980164
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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