MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC MONOTEX; PTFE (POLYTETRAFLUOROETHYLENE) WHITE MONOFILAMENT SUTURE

Model Number	T8001C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation initiated under complaint (b)(4).A separate complaint involving the same malfunction mode of two affected units were reported from lot 24090603 is being evaluated under a separate mdr 3009681798-2026-00021.The product was not returned for evaluation.A review of the device history records was performed and all product met requirements prior to release.No nonconformities were noted during production and all finished goods testing requirements were met prior to release.Retain samples from the affected lot were evaluated and passed all applicable testing requirements.There was no evidence that the device failed to meet specifications and the complaint could not be substantiated.A definitive root cause for the reported event could not be established.This report and use of categorical definitions required by fda form 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees caused or contributed to the event described in this report.Riverpoint medical has submitted this report in compliance with the medical device reporting requirements of 21 cfr part 803.If additional information becomes available, a supplemental mdr will be submitted as required.
Event or Problem Description
According to the reporter, "we received a complaint from our customer regarding the suture being off the needle on two units.We received another complaint this week for the same thing, but a different lot (lot #25052102)".

• Brand Name: MONOTEX
• Common Device Name: PTFE (POLYTETRAFLUOROETHYLENE) WHITE 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: 25194219
• Report Number: 3009681798-2026-00022
• Device Sequence Number: 18379150
• Product Code: NBY
• UDI-Device Identifier: 00812444020540
• UDI-Public: 00812444020540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: T8001C
• Device Lot Number: 25052102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown