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

Model Number CM-99529B

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

According to the reporter, "when inserting the juggerknot bb triple loaded, the anchor jammed inside the setting sleeve.After regular predrilling and insertion of the juggerknot anchor, an attempt was made to pull the inserter out of the setting sleeve.Due to the small inner lumen of the setting sleeve and the many threads, this was not easily possible.The user had to it the setting sleeve with a hammer to release the inserter and the setting sleeve.The soft anchor broke out.".

Manufacturer Narrative

No product was returned for evaluation at this time.A review of the device history record was performed and all product met requirements prior to release.The report could not be substantiated and 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 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: JUGGERKNOT SOFT ANCHOR
• Type of Device: TRIPLE LOADED IMPLANT
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 16029362
• MDR Text Key: 308369008
• Report Number: 3006981798-2022-00053
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K203740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2022

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 Operator: Health Professional
• Device Model Number: CM-99529B
• Device Lot Number: 22020311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1