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

Model Number	CM-99229B
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned and there were no retains available for review.Review of the dhr confirmed that all product requirements were met prior to release.The customer reported that there was a foreign material in the sealed pouch of this product.Photos provided enough evidence to confirm the complaint.Quality alerts 002-2026 and 010-2026 were issued to ensure proper adherence to clean room and inspection practices.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 (b)(6) or its employees that (b)(6) 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 (b)(6) 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 foreign substance which looks like a hair was found inside of the sterile package when the nurse opened the outer package.Therefore, the nurse prepared a back up product for the surgery.The complaint product is unopened product.".

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Common Device Name: DOUBLE 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 ; 5035178001
• MDR Report Key: 25669819
• Report Number: 3006981798-2026-00026
• Device Sequence Number: 17542042
• Product Code: MBI
• UDI-Device Identifier: 00810020087253
• UDI-Public: 00810020087253
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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-99229B
• Device Lot Number: 25080716
• 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: 06/08/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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