MAUDE Adverse Event Report: RIVERPOINT MEDICAL MONOTEX; SUTURE

Model Number	T8695C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and all products tested met finished goods testing requirements for the lot prior to release.Retains from the same lot were tested for needle attachment strength and tensile strength and all samples passed.The report could not be substantiated and a cause of 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 part 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "the needles were not attached to the suture.".

• Brand Name: MONOTEX
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 11504797
• Report Number: 3006981798-2021-00002
• Device Sequence Number: 19816461
• Product Code: NBY
• UDI-Device Identifier: 00812444020649
• UDI-Public: 00812444020649
• Combination Product (Y/N): N
• PMA/510(K) Number: K140415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: No Information
• Device Expiration Date: 02/28/2025
• Device Model Number: T8695C
• Device Lot Number: 20032508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1