MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX INTUBATION PAD & PLATE; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	AR-1627-10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical case: right shoulder open reduction.During surgical case, patient in beach chair position, beach chair malfunctioned: changing the patient¿s position from sitting upright to laying without intention of the surgical team.Surgery was completed as planned.

• Brand Name: ARTHREX INTUBATION PAD & PLATE
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 17640996
• Report Number: 17640996
• Device Sequence Number: 20838545
• Product Code: FWZ
• UDI-Device Identifier: 00888867020269
• UDI-Public: (01)00888867020269
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2023
• Report Date (Section F): 08/23/2023

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
• Device Model Number: AR-1627-10
• Device Catalogue Number: AR-1627-10
• Device Lot Number: 10241745/SN586828
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White
• Date Report Sent to FDA: 08/23/2023