MAUDE Adverse Event Report: Riverpoint Medical LLC Mono Q; Poliglecaprone 25 Undyed Monofilament Suture

Model Number	Q497
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, ""the office said that it would break as the doctor was tying it.".
Additional Manufacturer Narrative
Product was not returned.Retains from the reported lot were also tested and measured 28.7% above the usp minimum average requirement.All individual values met the minimum requirement.A review of the device history records was performed and all product met requirements prior to release.There were no nonconformities noted with the lot during production.There were no nonconformities with the raw material used.All finished goods testing requirements were met prior to release.There was no evidence that the device failed to meet specifications and the report could not substantiated.The report could not be substantiated and a cause for the event could not be established.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 its employees have caused or contributed to the event described in this report.Riverpoint medical has 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 the fda.

• Brand Name: Mono Q
• Common Device Name: Poliglecaprone 25 Undyed Monofilament Suture
• 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: 25736705
• Report Number: 3009681798-2026-00032
• Device Sequence Number: 13423298
• Product Code: GAM
• UDI-Device Identifier: 10812444021254
• UDI-Public: 10812444021254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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: Q497
• Device Lot Number: 25041706
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown