MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC ICONIX KNOTLESS; FIXATION DEVICE

Model Number	3911-714-522
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: "we were informed by a surgeon today that upon doing post-op x-rays in his office, he discovered a small piece of what he believed to be of a stryker knotless anchor that was in the shoulder.He stated this was his first time using the stryker knotless.We have already contacted our local stryker sale rep and let them know of the issue.He did not report knowing of any other issues with this anchor.".
Additional Manufacturer Narrative
The product was not returned for evaluation.A review of the device history record was performed and all product met requirements prior to release.There were no nonconformities noted with the lot during production.There were no nonconformities with the raw material used.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 substantiated.The report could not be substantiated and a cause for the event could not 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.

• Brand Name: ICONIX KNOTLESS
• Common Device Name: FIXATION DEVICE
• 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: 23866171
• Report Number: 3006981798-2025-00052
• Device Sequence Number: 5344295
• Product Code: MBI
• UDI-Device Identifier: 00840277404756
• UDI-Public: 00840277404756
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K231278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care 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: 3911-714-522
• Device Lot Number: 25042316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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