MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC FH LOOP; NONABSORBABLE SURGICAL SUTURE

Model Number	HS173
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "the customer say that the wire broke and it's not the first occurrence with other dispositifs of the same batch.".
Additional Manufacturer Narrative
The device was requested to be returned for evaluation, but has not been returned at this time.The quantity of devices with wire breaks was requested, but was not provided.The device history record was reviewed and there were no issues noted during production.All finished goods testing requirements were met prior to release.A cause for the event has not been established and the report cannot 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 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: FH LOOP
• Common Device Name: NONABSORBABLE SURGICAL 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: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 16960730
• Report Number: 3006981798-2023-00032
• Device Sequence Number: 5452668
• Product Code: GAT
• UDI-Device Identifier: 00810020083477
• UDI-Public: 0810020083477
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

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: HS173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown