MAUDE Adverse Event Report: RIVERPOINT MEDICAL, LLC MONOTEX; PTFE (POLYTETRAFLUORETHYLENE) WHITE MONOFILAMENT

Model Number	112-7256
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter "the sutures were breaking.There was no patient involved, and no complaint or no additional detail was provided.".
Additional Manufacturer Narrative
The device was returned for evaluation and suture tensile test and needle attachment testing was performed on the returned product.The product passed all tests and no nonconformities were found during testing.A review of the dhr for the lot was also performed and no issues were noted during the manufacturing and all finished goods testing requirements were met prior to lot release.This report and use of categorical definitions required by fda 3500a does not constitute an admission by 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.

• Brand Name: MONOTEX
• Common Device Name: PTFE (POLYTETRAFLUORETHYLENE) WHITE MONOFILAMENT
• Manufacturer (Section D): 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: 13746326
• Report Number: 3006981798-2022-00006
• Device Sequence Number: 4761976
• Product Code: NBY
• UDI-Device Identifier: 10304040001186
• UDI-Public: 10304040001186
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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
• Device Expiration Date: 05/31/2026
• Device Model Number: 112-7256
• Device Catalogue Number: 1127256
• Device Lot Number: 21062005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2021
• 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