MAUDE Adverse Event Report: Riverpoint Medical LLC JuggerKnot Soft Anchor; Single Loaded Implant

Model Number	CM-99114B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: JuggerKnot Soft Anchor
• Common Device Name: Single Loaded Implant
• 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 ; +1(503)517-8001
• MDR Report Key: 50810779
• Report Number: 3006981798-2026-00037
• Device Sequence Number: 8653746
• Product Code: MBI
• UDI-Device Identifier: 00810020087109
• UDI-Public: 00810020087109
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: CM-99114B
• Device Lot Number: 25080520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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