MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC RIBFIX TITAN; INTRATHORACIC ANCHOR

Model Number	323.5002
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or ithere were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior release.There was no evidence that the device failed to meet specifications and the report could not substantiated.A cause for the event cannot be established.Ts employees has cause or contributed to the event described in the report.Riverpoint medical filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by fda.
Event or Problem Description
According to the reporter, "it was reported in a case yesterday six internal bridges and 16 anchors were implant but used a total of 20 anchors.We had to remove four total anchors.We could not find one of the buttons after removal.It is believed one of the buttons fell in the chest cavity and was unretrievable after multiple hours of investigation.They ultimately closed up the patient after multiple x-rays, trying to locate the button, but was unsuccessful.".

• Brand Name: RIBFIX TITAN
• Common Device Name: INTRATHORACIC ANCHOR
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 22340452
• Report Number: 3006981798-2025-00026
• Device Sequence Number: 9024303
• Product Code: HTN
• UDI-Device Identifier: 00840277404459
• UDI-Public: 00840277404459
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 323.5002
• Device Lot Number: 24080908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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