MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; SURGICAL SUTURE

Model Number	SV935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to riverpoint for investigation.A dhr investigation was performed and no issues were noted with the lot during manufacturing.Product met all requirements prior to release.As part of riverpoint's investigation into the complaint, retains from the same lot were tested for finished goods testing and all samples passed.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.
Event or Problem Description
According to the reporter, "during second degree tear repair from birthing, when trying to anchor apex, needle broke as fine needle which is not utilized for muscle repair.A new suture was opened to complete the case.There was no patient injury.".

• Brand Name: VELOSORB FAST
• Common Device Name: SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave.; portland OR 97232
• MDR Report Key: 10617560
• Report Number: 3006981798-2020-00008
• Device Sequence Number: 3232576
• Product Code: GAM
• UDI-Device Identifier: 20884521151755
• UDI-Public: 20884521151755
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 03/31/2023
• Device Model Number: SV935
• Device Lot Number: 20042719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention