MAUDE Adverse Event Report: ROI CPS, LLC REGARD; ORTHO EXTEMITY

Model Number	OR00353M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Tear in the vented bag found prior to case set up.
Additional Manufacturer Narrative
Roi cps, llc performed an investigation into the casue of the damages to the vented bag containing the convenience kit.The results of the investigation were also provided to the end user facility reporting the event.See attached: "spartanburg closing letter".
Event or Problem Description
Tear in the vented bag found prior to case set up.

• Brand Name: REGARD
• Common Device Name: ORTHO EXTEMITY
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer; 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, MO 65738 ; 4176473205
• MDR Report Key: 20162335
• Report Number: 3014527682-2024-00021
• Device Sequence Number: 15295238
• Product Code: OJH
• UDI-Device Identifier: 10194717117391
• UDI-Public: (01)10194717117391(17)260426(10)100939
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 04/26/2026
• Device Model Number: OR00353M
• Device Catalogue Number: 800200013
• Device Lot Number: 100939
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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