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

Model Number	SV9915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
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 and no issues were noted during manufacturing and all finished goods testing requirements were met prior to lot release.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.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, "during a procedure, the needle detached from the thread and situated itself within the patient skin, a small incision was needed to remove the needle.".

• Brand Name: VELOSORB FAST
• Common Device Name: 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: amanda cole ; 825 ne 25th ave; portland, OR 97232 ; 5035178001
• MDR Report Key: 12910284
• Report Number: 3006981798-2021-00029
• Device Sequence Number: 11922470
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 05/21/2023
• Device Model Number: SV9915
• Device Lot Number: 20062313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown