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

Model Number	T8695C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "customer stated that soon as they pull the suture out of the sealed package the needle detaches from the thread.".
Additional Manufacturer Narrative
4 dozen return samples were obtained and needle attachment testing was performed per the usp standard.Needle attachment strength met all requirements.Tensile testing was also performed on the returned samples.Average tensile strength of the samples measured 86.6% above the usp requirement (0.44lbf) and the riverpoint requirement (0.44lbf) for size 6-0 ptfe.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.A cause for the event cannot 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 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.

• 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: 25316910
• Report Number: 3009681798-2026-00023
• Device Sequence Number: 9985876
• Product Code: NBY
• UDI-Device Identifier: 00812444020649
• UDI-Public: 00812444020649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: T8695C
• Device Lot Number: 26012207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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