MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC JUGGERKNOT SOFT ANCHOR; BONE FIXATION FASTENER

Model Number CM-99129BN

Device Problem Device Handling Problem (3265)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.A review of the dhr for the lot was performed and not issues were noted during manufacturing and all finished goods testing requirements were met prior to lot release.Investigations performed did not reveal any issues with the product and the report could not be substantiated.This report and use of categorical definitions required by fda 3500a does not constitute an admission by 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 part 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

Event Description

According to the reporter, "2.9 juggerknots were used with proper technique during the procedure.Each item attached failed to properly deploy when attempting to place anchor into the patient.Product failure during foot and ankle soft tissue repair (modified brostrum) and ankle syndesmosis on (b)(6) 2022".

• Brand Name: JUGGERKNOT SOFT ANCHOR
• Type of Device: BONE FIXATION FASTENER
• Manufacturer (Section D): 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: 13564284
• MDR Text Key: 288655542
• Report Number: 3006981798-2022-00005
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00810020087192
• UDI-Public: 00810020087192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2022

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-99129BN
• Device Lot Number: 21030833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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