MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC MAXIMA PGA; SURGICAL SUTURE

Model Number	570-1047
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and tensile tested.Four retained samples from the same lot were used to perform a knot pull tensile test.The retained and returned samples used for the knot pull tensile test met requirements.Production records were reviewed.There were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior to release.There was no evidence that the device failed to meet specifications, and the report could not be substantiated.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 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 customer reports that the sutures are breaking and feel much thinner than a 3-0 should.The customer states that they have witnessed the suture filament break with very little tension while placing sutures.Also for the first time they had a patient who came in with a superficial running suture that had broken.The end of the running suture line where the final knot was placed was gone and the free end was frayed, suggesting breakage of the suture and not a slipped knot.So they had to numb the patient and resuture as well as secure the free end of the running cuticular suture.".

• Brand Name: MAXIMA PGA
• Common Device Name: 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 ; 5035178001
• MDR Report Key: 24571899
• Report Number: 3009681798-2026-00008
• Device Sequence Number: 8355363
• Product Code: GAN
• UDI-Device Identifier: 00304040081358
• UDI-Public: 00304040081358
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K100461
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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 Model Number: 570-1047
• Device Lot Number: 25042404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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