MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC VELOSORB FAST; BRAIDED FAST ABSORBABLE SUTURE

Model Number	SV-494
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.A review of the dhr for the lot was performed and no issues were noted during manufacturing.Retain samples from the same lot were tested for finished goods testing, including tensile strength and needle attachment tesing.Test results show that all retains passed.Investigations performed did not reveal any issues with the product and the report could not be substantiated.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 provdided 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, "during an open procedure, the needle of the suture detached from the thread and fell into patient's cavity.The surgery was extended by 30 minutes or more to find the fallen needle but then it was retrieved and procedure was completed.No patient injury.".

• Brand Name: VELOSORB FAST
• Common Device Name: BRAIDED FAST ABSORBABLE 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 ; 5035178001
• MDR Report Key: 14605650
• Report Number: 3006981798-2022-00011
• Device Sequence Number: 6146801
• Product Code: GAM
• UDI-Device Identifier: 10884521151130
• UDI-Public: 10884521151130
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: SV-494
• Device Lot Number: 21033003FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown