MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; SUTURE

Model Number	SV-9915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
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 suture tensile strength and needle attachment testing.Test results show that all retain samples passed.Investigations performed did not reveal any issues with the product and the report could not be substantiated.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, "pre-operatively, when preparing the needle in needle holder and needle snapped off from suture.There was no patient involved.".

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 12681997
• Report Number: 3006981798-2021-00027
• Device Sequence Number: 5723619
• Product Code: GAM
• UDI-Device Identifier: 20884521153285
• UDI-Public: 20884521153285
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: SV-9915
• Device Lot Number: 2102111FX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1