MAUDE Adverse Event Report: ROI CPS, LLC REGARD¿; MAJOR EXTREMITY

Model Number	OR00922D
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The orange laminated # 2 was found inside the pack between the split drapes.The tech did not realize until they were draping the patient.The entire surgical setup had to be broken down prior to starting the surgery.This caused a case delay with patient asleep on the table.The # 2 has old tape on it almost like it came from a workstation in a factory.

• Brand Name: REGARD¿
• Common Device Name: MAJOR EXTREMITY
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS., LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic; 4176473205
• MDR Report Key: 20557853
• Report Number: 3014527682-2024-00023
• Device Sequence Number: 15698015
• Product Code: OJH
• UDI-Device Identifier: 10194717115816
• UDI-Public: (01)10194717115816(17)260505(10)102387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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 Expiration Date: 05/05/2026
• Device Model Number: OR00922D
• Device Lot Number: 102387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown