MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC FH LOOP TAPE; BLACK UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE WHIP STITCH SUTURE TAPE

Model Number	HS523
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and will not be returned.Product records were reviewed.There were no conformities noted with the lot during production.All finished goods testing requirements were met prior to release, including needle attachment.There was no evidence that the device failed to meet specifications, and the report could not be substantiated.
Event or Problem Description
According to the reporter, "needle loosened during use.Change of equipment.This is an isolated incident only on one item.The customer concerned is in france.According to the information in the customer's statement, there were no consequences, another device was used instead.".

• Brand Name: FH LOOP TAPE
• Common Device Name: BLACK UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE WHIP STITCH SUTURE TAPE
• 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: 21699299
• Report Number: 3006981798-2025-00019
• Device Sequence Number: 15377512
• Product Code: GAT
• UDI-Device Identifier: 00840277405937
• UDI-Public: 00840277405937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190817
• 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): 03/20/2025

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: HS523
• Device Lot Number: 24052820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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