MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC SALVIN SURGIPOINT; (POLIGRLECAPRONE 25) VIOLET MONOFILAMENT

Model Number	Q392C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "units broke during surgery.".
Additional Manufacturer Narrative
A review of the device history record was performed and all product met finished goods testing requirements for the lot prior to release.Retained samples from the same lot were tested for tensile strength and moisture and all samples passed.The report could not be substantiated and a cause for the event cannot 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 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

• Brand Name: SALVIN SURGIPOINT
• Common Device Name: (POLIGRLECAPRONE 25) VIOLET MONOFILAMENT
• 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 ; 5038178001
• MDR Report Key: 15322815
• Report Number: 3006891798-2022-00028
• Device Sequence Number: 12234416
• Product Code: GAM
• UDI-Device Identifier: 00810020081879
• UDI-Public: 00810020081879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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 Model Number: Q392C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown