MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; SELF PUNCHING TRIPLE LOADED IMPLANT

Model Number	SP99529B
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "attached is the event information from the 3 broken juggernauts at (b)(6) hospital.I will also attach pictures of the broken products if that helps.We have tried 6x with this product, all anchors had the same lot # 23081820, 3 were successful and 3 failed.".
Additional Manufacturer Narrative
The device was not returned.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 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 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.

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Common Device Name: SELF PUNCHING TRIPLE 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: 19081910
• Report Number: 3006981798-2024-00027
• Device Sequence Number: 20763798
• Product Code: MBI
• UDI-Device Identifier: 00840277402431
• UDI-Public: 00840277402431
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: SP99529B
• Device Lot Number: 23081820
• 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: 03/14/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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