MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC BROADBAND MENISCAL NEEDLES; NON-ABSORBABLE UHMWPE SUTURE

Model Number	CM-0307N
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "it was reported that the knee joint of a patient who has been implanted the complaint product came to make abnormal noise when extension and flexion.Currently, no further action is planned for the patient." "it's difficult to express, but it was reported that it like a something creaking(gyu, gyu, gyu, or squish, squish, squish?)[?] it was reported that the patient experiencing no pain.".
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.There was no evidence that the device failed to meet specifications and the report could not substantiated.The ifu for this device (pub366) was reviewed and found to contain sufficient instructions for use and warnings/precautions.There is a possibility of using the incorrect surgical method for implanting the inserter.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 has cause or contributed to the event described in the report.Riverpoint medical 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 fda.

• Brand Name: BROADBAND MENISCAL NEEDLES
• Common Device Name: NON-ABSORBABLE UHMWPE 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: 23866221
• Report Number: 3006981798-2025-00053
• Device Sequence Number: 4450962
• Product Code: GAT
• UDI-Device Identifier: 00810020081275
• UDI-Public: 00810020081275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153307
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: CM-0307N
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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