MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC PROCINCH; WHITE POLYBLEND UHMWPE NON-ABSORBABLE SUTURE WITH TITANIUM BUTTON

Model Number	234-102-065
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evalution.A review of the device history record was performed and all product met requirements prior to release.A visual of the affected device was sent to riverpoint for analysis.The analysis concluded an error may have occured during manufacturing assembly of the device.The lot retains underwent visual inspection and all product passed inspection.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.
Event or Problem Description
According to the reporter, "the pa constructed the open loop procinch at the back table following all manufacturers instructions, and when they pulled the graft down and away from the card, the cinching mechanism wouldn't pull into the center holes of the procinch button.One of the loops was through the button, and the other did not pass through any holes on the button.Both white sutures creating loops should be through center holes of the button.".

• Brand Name: PROCINCH
• Common Device Name: WHITE POLYBLEND UHMWPE NON-ABSORBABLE SUTURE WITH TITANIUM BUTTON
• 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: 15170607
• Report Number: 3006981798-2022-00024
• Device Sequence Number: 5073096
• Product Code: MBI
• UDI-Device Identifier: 00810020081978
• UDI-Public: 00810020081978
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202399
• 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): 08/04/2022

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: 234-102-065
• Device Lot Number: 21111830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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