MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; SINGLE LOADED IMPLANT

Model Number	CM-99115
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.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.There is a possibility of using the incorrect surgical method for implanting the inserter.Furthermore, if the drill channel is too small or the bone quality is not of acceptable form, this kind of failure is possible.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.
Event or Problem Description
According to the reporter, "it was reported that during the surgery, the tip of inserter of this complaint product's device was fractured during use.The surgery was finished without removing the fractured piece of inserter from the patient's body, and it was confirmed that the fractured piece of inserter has been remained in the patient's body by x-ray.".

• 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
• MDR Report Key: 23027138
• Report Number: 3006981798-2025-00031
• Device Sequence Number: 18445738
• Product Code: MBI
• UDI-Device Identifier: 00810020087147
• UDI-Public: 00810020087147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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
• Device Model Number: CM-99115
• Device Lot Number: 22022416
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• 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